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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01850524




Registration number
NCT01850524
Ethics application status
Date submitted
26/04/2013
Date registered
6/05/2013
Date last updated
9/05/2018

Titles & IDs
Public title
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
Scientific title
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral IXAZOMIB (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
Secondary ID [1] 0 0
2013-000326-54
Secondary ID [2] 0 0
C16014
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 - IXAZOMIB + Lenalidomide + Dexamethasone
Treatment: Drugs - Placebo + Lenalidomide + Dexamethasone

Active Comparator: IXAZOMIB - IXAZOMIB + Lenalidomide + Dexamethasone

Placebo Comparator: Placebo - Placebo + Lenalidomide + Dexamethasone


Treatment: Drugs: IXAZOMIB + Lenalidomide + Dexamethasone
Patients will receive single oral dose of IXAZOMIB (4.0mg) on days 1,8,15 and single oral dose of Lenalidomide (25mg) on days 1-21 and single oral dose of Dexamethasone (40mg) on days 1,8, 15 and 22 every 28 days for the first 18 cycles or until progressive disease or unacceptable toxicity, whichever comes first.
After cycle 18 IXAZOMIB and Lenalidomide will be reduced and Dexamethasone will be discontinued.

Treatment: Drugs: Placebo + Lenalidomide + Dexamethasone
Patients will receive single oral dose of Placebo on days 1,8,15 and single oral dose of Lenalidomide (25mg) on days 1-21 and single oral dose of Dexamethasone (40mg) on days 1,8, 15 and 22 every 28 days for the first 18 cycles or until progressive disease or unacceptable toxicity, whichever comes first.
After cycle 18 IXAZOMIB and Lenalidomide will be reduced and Dexamethasone will be discontinued.

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

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS) - PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease or death due to any cause, whichever occurs first.
Timepoint [1] 0 0
PFS will be assessed at every cycle during the treatment period and subsequently every 4 weeks until disease progression (median length of the endpoint assessment period is projected to be approximately 30 months).
Secondary outcome [1] 0 0
Complete Response (CR) - Standard multiple myeloma disease assessment
Timepoint [1] 0 0
Response assessments will occur every cycle during the treatment period and subsequently every 4 weeks during the PFS follow-up period until disease progression (median length of the endpoint assessment period is projected to be approximately 30 months).
Secondary outcome [2] 0 0
Pain response rate as assessed by the BPI-SF and analgesic use
Timepoint [2] 0 0
BPI-SF will be assessed at every cycle during the treatment period and subsequently every 4 weeks during the PFS follow-up period until disease progression (median length of the endpoint assessment period is projected to be approximately 30 months).
Secondary outcome [3] 0 0
Overall Survival (OS) - OS is defined as the time from the date of randomization to the date of death.
Timepoint [3] 0 0
OS will be assessed at every cycle during the treatment period and subsequently every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination (approximate length of the overall survival period is 60 month)

Eligibility
Key inclusion criteria
- Male or female patients 18 years or older diagnosed with Multiple Myeloma according to
standard criteria who have not received prior treatment

- Patients for whom lenalidomide and dexamethasone treatment is appropriate and who are
not eligible for high-dose therapy followed by stem-cell transplantation (HDT-SCT) for
1 or more of the following reasons:

1. the patient is 65 years of age or older

2. the patient is less than 65 years of age but has significant comorbid
condition(s) that are, in the opinion of the investigator, likely to have a
negative impact on tolerability of HDT-SCT

- Measurable disease as specified in study protocol

- Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 2

- Meet the clinical laboratories criteria as specified in the protocol

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or agree to practice true abstinence, and must also
agree to ongoing pregnancy testing; must also adhere to the guidelines of the
lenalidomide pregnancy prevention program

- Male patients who agree to practice effective barrier contraception or agree to
practice true abstinence AND must adhere to the guidelines of the lenalidomide
pregnancy prevention program

- Suitable venous access for the study-required blood sampling

- Must be able to take concurrent aspirin 70mg to 325 mg daily (or enoxaparin if aspirin
allergic)

- Voluntary written consent

- Patient is willing and able to adhere to the study visit schedule and other protocol
requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment for multiple myeloma with either standard of care treatment or
investigational regimen

- Diagnosed and treated for another malignancy within 5 years before randomization or
previously diagnosed with another malignancy and have any evidence of residual
disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
not excluded if they have undergone complete resection

- Inability or unwillingness to receive antithrombotic therapy

- Female patients who are lactating or pregnant

- Major surgery or radiotherapy within 14 days before randomization

- Infection requiring intravenous antibiotics within 14 days before the first dose of
study drug

- Central nervous system involvement

- Diagnosis of Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia,
primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome

- Evidence of current uncontrolled cardiovascular conditions

- Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin,
ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin,
itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A
inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital),
or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the
study

- Active hepatitis B or C virus infection, or known human immunodeficiency virus(HIV)
positive

- Comorbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or
higher of any cause)

- Serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to the protocol

- Known allergy to any of the study medications

- 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

- Treatment with any investigational products within 60 days before the first dose of
the study drug regimen

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Millennium Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and
efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in
patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell
transplant.
Trial website
https://clinicaltrials.gov/show/NCT01850524
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Millennium Pharmaceuticals, Inc.
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

No data has been provided for results reporting
Summary results
Other publications