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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02312258




Registration number
NCT02312258
Ethics application status
Date submitted
5/12/2014
Date registered
9/12/2014

Titles & IDs
Public title
A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
Scientific title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
Secondary ID [1] 0 0
U1111-1160-1702
Secondary ID [2] 0 0
C16021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ixazomib

Placebo comparator: Placebo - Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Experimental: Ixazomib - Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.


Treatment: Drugs: Placebo
Ixazomib placebo-matching capsules.

Treatment: Drugs: Ixazomib
Ixazomib capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
Secondary outcome [2] 0 0
Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period
Timepoint [2] 0 0
Up to 27 months
Secondary outcome [3] 0 0
Time to Progression (TTP)
Timepoint [3] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [4] 0 0
Progression Free Survival 2 (PFS2)
Timepoint [4] 0 0
From the date of randomization to every 12 weeks until second PD or death (up to 88 months)
Secondary outcome [5] 0 0
Time to Next Line Therapy (TTNT)
Timepoint [5] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [6] 0 0
Time to End of the Next-line of Therapy After Study Treatment
Timepoint [6] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [7] 0 0
Duration of Next-line Therapy
Timepoint [7] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [8] 0 0
Percentage of Participants Who Develop a New Primary Malignancy
Timepoint [8] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [9] 0 0
Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative
Timepoint [9] 0 0
Up to 52 months
Secondary outcome [10] 0 0
Correlation of MRD Status With PFS and OS
Timepoint [10] 0 0
From randomization up to 52 months
Secondary outcome [11] 0 0
OS in a High-risk Population
Timepoint [11] 0 0
From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
Secondary outcome [12] 0 0
PFS in a High-risk Population
Timepoint [12] 0 0
From randomization until PD or death (up to 52 months)
Secondary outcome [13] 0 0
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [13] 0 0
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)
Secondary outcome [14] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [14] 0 0
First dose of study drug through 30 days after last dose of study drug (up to 88 months)
Secondary outcome [15] 0 0
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)
Timepoint [15] 0 0
Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)
Secondary outcome [16] 0 0
Correlation Between Frailty Status and PFS and OS
Timepoint [16] 0 0
From randomization up to 52 months
Secondary outcome [17] 0 0
Pharmacokinetic Parameter: Plasma Concentration of Ixazomib
Timepoint [17] 0 0
Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)
Secondary outcome [18] 0 0
Time to Resolution of Peripheral Neuropathy (PN) Events
Timepoint [18] 0 0
Up to 52 months
Secondary outcome [19] 0 0
Time to Improvement of PN Events
Timepoint [19] 0 0
Up to 52 months

Eligibility
Key inclusion criteria
1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
2. Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
3. Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.
4. Female participants who:

* Are postmenopausal for at least 1 year before the screening visit, OR
* Are surgically sterile, OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)

Male participants, even if surgically sterilized (that is, status postvasectomy), who:
* Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
5. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
6. Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
7. Eastern Cooperative Oncology Group Performance Status of 0 to 2.
8. Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
9. Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
10. Must meet the following clinical laboratory criteria at study entry:

* Absolute neutrophil count (ANC) greater than or equal to (=) 1,000 per cubic millimeter (/mm^3) without growth factor support and platelet count =75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization.
* Total bilirubin less than or equal to (=) 1.5*the upper limit of the normal range (ULN).
* Alanine aminotransferase and aspartate aminotransferase = 3*ULN.
* Calculated creatinine clearance = 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.
2. Prior SCT.
3. Radiotherapy within 14 days before randomization.
4. Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
6. Major surgery within 14 days before randomization.
7. Central nervous system involvement.
8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
9. Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
11. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.
12. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
13. Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).
14. Psychiatric illness or social situation that would limit compliance with study requirements.
15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
17. Treatment with any investigational products within 30 days before randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2022
Sample size
Target
Accrual to date
Final
706
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - PPDS - Fitzroy
Recruitment hospital [2] 0 0
Frankston Hospital - Frankston
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
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Texas
Country [14] 0 0
United States of America
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Washington
Country [15] 0 0
United States of America
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West Virginia
Country [16] 0 0
Argentina
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Ciudad Autonoma De BuenosAires
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Argentina
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Cordoba
Country [18] 0 0
Argentina
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Santa Fe
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Austria
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Tirol
Country [20] 0 0
Austria
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Salzburg
Country [21] 0 0
Austria
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Wels
Country [22] 0 0
Austria
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Wien
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Belgium
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Brussels
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Brazil
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Bahia
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Brazil
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Goias
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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Rio Grande Do Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Brazil
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Rio de Janeiro
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Brazil
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Sao Jose Do Rio Preto
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucanía
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Chile
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Santiago
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Chile
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Vina Del Mar
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China
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Shenyang
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Taiyuan
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China
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Wuhan
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Colombia
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Antioquia
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Colombia
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Cundinamarca
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Colombia
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Distrito Capital De Bogota
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Grad Zagreb
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Rijeka
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Zagreb
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Czechia
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Kralovehradeck Kraj
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Czechia
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Praha, Hlavni Mesto
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Praha 2
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Denmark
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Capital
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Denmark
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Aarhus N
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Denmark
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Holstebro
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Denmark
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Odense
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France
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Hauts-de-Seine
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France
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Loire-Atlantique
Country [66] 0 0
France
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Meurthe-et-Moselle
Country [67] 0 0
France
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Dijon
Country [68] 0 0
France
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Lille
Country [69] 0 0
France
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Paris
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France
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Pessac
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France
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Poitiers
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France
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Rennes
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Landshut
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Germany
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Munchen
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Germany
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Rosenheim
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Germany
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Wurzburg
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Greece
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Attiki
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Israel
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Be'er Sheva
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Israel
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Beer Yaakov
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Tiberias
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Ancona
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Italy
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Firenze
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Italy
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Parma
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Italy
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Ravenna
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Italy
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Torino
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Japan
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Gihu
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Nara
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Japan
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Okayama
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Fukushima-City
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Japan
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Kurume
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Japan
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Nagaizumi-cho
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Japan
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Nagoya
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Japan
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Narita-shi
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Japan
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Niigata-city
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Japan
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Osaka
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Japan
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Tachikawa
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Japan
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Toyohashi
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Japan
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Yamanashi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
State/province [133] 0 0
Incheon
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Mexico City
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Mexico
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Oaxaca
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Poland
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Chorzow
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Poland
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Almada
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Portugal
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Braga
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Portugal
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Porto
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Russian Federation
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Kirov
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Russian Federation
State/province [148] 0 0
Pyatigorsk
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Ryazan
Country [150] 0 0
Russian Federation
State/province [150] 0 0
St. Petersburg
Country [151] 0 0
Serbia
State/province [151] 0 0
Belgrade
Country [152] 0 0
Serbia
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Kragujevac
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Serbia
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Nis
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Singapore
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Singapore
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South Africa
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Gauteng
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Spain
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Barcelona
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Spain
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Madrid, Communidad Delaware
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Sodermanlands Lan
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Sweden
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Vastra Gotalands Lan
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Sweden
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Lund
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Switzerland
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Thun
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Taiwan
State/province [167] 0 0
Kaohsiung
Country [168] 0 0
Taiwan
State/province [168] 0 0
Taichung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Taipei
Country [170] 0 0
Thailand
State/province [170] 0 0
Krung Thep Maha Nakhon
Country [171] 0 0
Thailand
State/province [171] 0 0
Bangkok
Country [172] 0 0
Thailand
State/province [172] 0 0
Chiangmai
Country [173] 0 0
Turkey
State/province [173] 0 0
Ankara
Country [174] 0 0
Turkey
State/province [174] 0 0
Istanbul
Country [175] 0 0
Turkey
State/province [175] 0 0
Izmir
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Antrim
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Birmingham
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Bristol, City Of
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Dorset
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Hampshire
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Kent
Country [182] 0 0
United Kingdom
State/province [182] 0 0
London, City Of
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Oxfordshire
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Staffordshire
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Surrey
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Bath
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Belfast
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Bristol
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Cardiff
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Isleworth
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Leicester
Country [192] 0 0
United Kingdom
State/province [192] 0 0
London
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Manchester
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Middlesex
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Oldham
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Southall
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02312258