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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03170882




Registration number
NCT03170882
Ethics application status
Date submitted
22/05/2017
Date registered
31/05/2017

Titles & IDs
Public title
A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma
Scientific title
A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2016-004742-28
Secondary ID [2] 0 0
C16029
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed and/or Refractory 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 - Ixazomib
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone

Active comparator: Pomalidomide 4 mg + Dexamethasone 40 mg - Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

Experimental: Ixazomib 4 mg + Dexamethasone 20 mg - Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.


Treatment: Drugs: Ixazomib
Ixazomib capsules

Treatment: Drugs: Pomalidomide
Pomalidomide capsules

Treatment: Drugs: Dexamethasone
Dexamethasone tablets
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 date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of randomization to death due to any cause (Up to approximately 3 years)
Secondary outcome [2] 0 0
Percentage of Participants With Overall Response
Timepoint [2] 0 0
From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
Secondary outcome [4] 0 0
Time to Response
Timepoint [4] 0 0
From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
Secondary outcome [5] 0 0
Time to Progression (TTP)
Timepoint [5] 0 0
From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)
Secondary outcome [6] 0 0
Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score
Timepoint [6] 0 0
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary outcome [7] 0 0
HRQOL Based on EORTC QLQ-C30 SubScale Score
Timepoint [7] 0 0
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary outcome [8] 0 0
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score
Timepoint [8] 0 0
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary outcome [9] 0 0
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score
Timepoint [9] 0 0
End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary outcome [10] 0 0
HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score
Timepoint [10] 0 0
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Secondary outcome [11] 0 0
Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
HU: Duration of Medical Encounters
Timepoint [12] 0 0
Up to approximately 3 years

Eligibility
Key inclusion criteria
1. Must have a confirmed diagnosis of multiple myeloma (MM) requiring therapy according to International Myeloma Working Group (IMWG) criteria.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
3. Must have had a relapse or progressive disease (PD) after having received 2 or more prior lines of systemic therapy. Note: A line of therapy is defined as 1 or more cycles of a planned treatment program; this may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem cell transplantation (SCT), followed by maintenance is considered 1 line of therapy. Typically each line of therapy is separated by PD. Discussion with the medical monitor may help clarify the number of lines of therapy that a prospective study participant had.
4. Must be refractory to lenalidomide, defined as having received at least 2 consecutive cycles of lenalidomide as a single agent or within a lenalidomide-containing regimen and having had PD during treatment with or within 60 days after the last dose of lenalidomide. The starting dose of lenalidomide should have been 25 mg (or as low as 10 mg in the case of renal function impairment or other safety concern), and the final dose should have been a minimum of 10 mg.
5. Must have received at least 2 consecutive cycles of a bortezomib- or carfilzomib-containing regimen, and either:

* Achieved at least a partial response (PR) and did not have PD during treatment with or within 60 days after the last dose of bortezomib or carfilzomib, OR
* Had bortezomib and/or carfilzomib intolerance (defined as discontinuation because of drug-related adverse events [AEs] before completion of the planned treatment course) without PD before the start of the next regimen.
6. Must have measurable disease defined by:

* Serum M-protein >=1 g/dL (>=10 g/L), OR
* Urine M-protein >=200 mg/24 hours and must have documented MM isotype by immunofixation (central laboratory).
7. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
8. Recovered (that is, less than or equal to [<=] Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy.
9. Must be willing and able to adhere to pomalidomide-related risk mitigation activities if randomized to the pom+dex arm (example, Risk Evaluation and Mitigation Strategies [REMS], pregnancy prevention programs).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior allogenic bone marrow transplantation in any prior line of therapy or prior autologous SCT in the last prior line of therapy- unless the autologous SCT was performed a year or more before disease progression.
2. Diagnosed with or treated for another malignancy within 2 years before randomization, or previously diagnosed with another malignancy and have any evidence of residual, persistent, or recurrent disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
3. Diagnosis of smoldering MM, Waldenström's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
4. Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
5. Treatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: "spot" radiation for areas of pain is permitted), and major surgery within 14 days before randomization.
6. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of study therapy, including difficulty swallowing.
7. Serious infection requiring parenteral antibiotic therapy or any other serious infection within 14 days before randomization.
8. Central nervous system involvement with MM (by clinical symptoms and signs).
9. Ongoing or active systemic infection, known human immunodeficiency virus-ribonucleic acid (RNA) positive, known hepatitis B surface antigen seropositive, or known hepatitis C virus-RNA positive.
10. Systemic treatment with strong cytochrome P-450 3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or use of St. John's wort within 14 days before randomization.
11. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
12. History of severe cutaneous reactions, including hypersensitivity reactions such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), in the context of treatment with lenalidomide or thalidomide.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/11/2021
Sample size
Target
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Brugge
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Czechia
State/province [12] 0 0
Kralovehradeck Kraj
Country [13] 0 0
Czechia
State/province [13] 0 0
Olomouck Kraj
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha, Hlavni Mesto
Country [15] 0 0
Czechia
State/province [15] 0 0
Brno
Country [16] 0 0
Czechia
State/province [16] 0 0
Ostrava
Country [17] 0 0
Czechia
State/province [17] 0 0
Plzen Lochotin
Country [18] 0 0
Denmark
State/province [18] 0 0
Nordjylland
Country [19] 0 0
Denmark
State/province [19] 0 0
Holstebro
Country [20] 0 0
France
State/province [20] 0 0
Alpes-Maritimes
Country [21] 0 0
France
State/province [21] 0 0
Cote-d'Or
Country [22] 0 0
France
State/province [22] 0 0
Finistere
Country [23] 0 0
France
State/province [23] 0 0
Meurthe-et-Moselle
Country [24] 0 0
France
State/province [24] 0 0
Morbihan
Country [25] 0 0
France
State/province [25] 0 0
Sarthe
Country [26] 0 0
France
State/province [26] 0 0
Seine-Maritime
Country [27] 0 0
France
State/province [27] 0 0
Amiens
Country [28] 0 0
France
State/province [28] 0 0
Bourg-en- Bresse Cedex
Country [29] 0 0
France
State/province [29] 0 0
Chalon sur Saone
Country [30] 0 0
France
State/province [30] 0 0
Clamart
Country [31] 0 0
France
State/province [31] 0 0
Dunkerque
Country [32] 0 0
France
State/province [32] 0 0
Le Mans cedex 2
Country [33] 0 0
France
State/province [33] 0 0
Orleans
Country [34] 0 0
France
State/province [34] 0 0
Perigueux
Country [35] 0 0
France
State/province [35] 0 0
Poitiers
Country [36] 0 0
France
State/province [36] 0 0
Rennes Cedex 9
Country [37] 0 0
France
State/province [37] 0 0
Rouen
Country [38] 0 0
Germany
State/province [38] 0 0
Bayern
Country [39] 0 0
Germany
State/province [39] 0 0
Dusseldorf
Country [40] 0 0
Germany
State/province [40] 0 0
Hamburg
Country [41] 0 0
Germany
State/province [41] 0 0
Tubingen
Country [42] 0 0
Greece
State/province [42] 0 0
Achaia
Country [43] 0 0
Greece
State/province [43] 0 0
Alexandroupoli
Country [44] 0 0
Greece
State/province [44] 0 0
Athens
Country [45] 0 0
Greece
State/province [45] 0 0
Ioannina
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Israel
State/province [47] 0 0
Beer Sheva
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Jerusalem
Country [50] 0 0
Italy
State/province [50] 0 0
Emilia-Romagna
Country [51] 0 0
Italy
State/province [51] 0 0
Marche
Country [52] 0 0
Italy
State/province [52] 0 0
Piemonte
Country [53] 0 0
Italy
State/province [53] 0 0
PZ
Country [54] 0 0
Italy
State/province [54] 0 0
Aviano
Country [55] 0 0
Italy
State/province [55] 0 0
Brescia
Country [56] 0 0
Italy
State/province [56] 0 0
Meldola
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Modena
Country [59] 0 0
Italy
State/province [59] 0 0
Parma
Country [60] 0 0
Italy
State/province [60] 0 0
Udine
Country [61] 0 0
Italy
State/province [61] 0 0
Vicenza
Country [62] 0 0
Netherlands
State/province [62] 0 0
Zuid-Holland
Country [63] 0 0
Netherlands
State/province [63] 0 0
Sittard
Country [64] 0 0
Norway
State/province [64] 0 0
Oppland
Country [65] 0 0
Norway
State/province [65] 0 0
Bergen
Country [66] 0 0
Norway
State/province [66] 0 0
Forde
Country [67] 0 0
Norway
State/province [67] 0 0
Stavanger
Country [68] 0 0
Norway
State/province [68] 0 0
Trondheim
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Kirov
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Samara
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid, Communidad Delaware
Country [73] 0 0
Spain
State/province [73] 0 0
Girona
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
Sweden
State/province [75] 0 0
Skane Lan
Country [76] 0 0
Sweden
State/province [76] 0 0
Boras
Country [77] 0 0
Sweden
State/province [77] 0 0
Umea
Country [78] 0 0
Turkey
State/province [78] 0 0
Ankara
Country [79] 0 0
Turkey
State/province [79] 0 0
Izmir
Country [80] 0 0
Turkey
State/province [80] 0 0
Kayseri
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Cornwall
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Denbighshire-SirDdinbych
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Dorset
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Kent
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Oxfordshire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Staffordshire
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Leicester
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Swansea
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Millennium Pharmaceuticals, Inc.
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/NCT03170882