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Clinical trial

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM)

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Last updated:7th Jan 2013
Identifier: NCT01734928

The purpose of this study is to compare the efficacy of the combination of Pomalidomide, Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of Bortezomib and Dexamethasone


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date: January 7, 2013
Actual Primary Completion Date: October 26, 2017
Estimated Study Completion Date: April 24, 2022

Arm:
- Experimental:
Pomalidomide, Bortezomib and Low Dose Dexamethasone
- Active Comparator: Bortezomib and Low Dose Dexamethasone

Category Value
Date last updated at source 2018-05-31
Study type(s) Interventional
Expected enrolment 559
Study start date 2013-01-07
Estimated primary completion date 2017-10-26

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