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A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

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Last updated:1st Aug 2012
Identifier: NCT01564537

The purpose of this phase 3, randomized, double-blind, multicenter study is to compare Oral Ixazomib (MLN9708) plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 Relapsed and/or Refractory Multiple Myeloma
Enrollment: 837
Study Start Date: August 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator:
ixazomib
- Placebo Comparator: Placebo


Related journal:
- Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
-
Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.

Category Value
Date last updated at source 2017-09-06
Study type(s) Interventional
Expected enrolment 722
Study start date 2012-08-01
Estimated primary completion date 2014-10-01

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