Last updated on March 2019

Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting


Brief description of study

This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.

This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.

This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.

Detailed Study Description

A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.

This trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.

Clinical Study Identifier: NCT01946477

Find a site near you

Start Over

Marin Oncology Associates

Greenbrae, CA United States
  Connect »

Stamford Hospital

Stamford, CT United States
  Connect »

Cancer Specialist of North Florida

Jacksonville, FL United States
  Connect »

Memorial West Cancer Institute

Pembroke Pines, FL United States
  Connect »

Carroll Regional Cancer Center

Westminster, MD United States
  Connect »

St. Luke's Hospital

Kansas City, MO United States
  Connect »

Washington University

Saint Louis, MO United States
  Connect »

CR Wood Cancer Center

Glens Falls, NY United States
  Connect »

Cleveland Clinic

Cleveland, OH United States
  Connect »

Cleveland Clinic

Mayfield Heights, OH United States
  Connect »

Tennessee Oncology

Chattanooga, TN United States
  Connect »

Tennessee Oncology, PLLC

Nashville, TN United States
  Connect »

Joe Arrington Cancer Center

Lubbock, TX United States
  Connect »

Cancer Care Northwest

Spokane, WA United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.