Last updated on June 2018

A Study Of Daratumumab Low-Dose Oral Dexamethasone and Cyclophosphamide With Or Without Pomalidomide


Brief description of study

This is a randomized phase II open label study of daratumumab, weekly low-dose oral cyclophosphamide and dexamethasone with or without pomalidomide in patients with relapsed and refractory multiple myeloma. The study consists of two arms. Patients will be randomized into ARM A and ARM B in a 1:1 ratio.

Detailed Study Description

This is a randomized phase II open label study of daratumumab, weekly low-dose oral cyclophosphamide and dexamethasone with or without pomalidomide in patients with relapsed and refractory multiple myeloma. The study consists of two arms. Patients will be randomized into ARM A and ARM B in a 1:1 ratio.

In treatment ARM A patients will receive daratumumab, cyclophosphamide, dexamethasone and pomalidomide as per the following schedule:

  • Daratumumab, IV, at 16 mg/kg on days 1, 8, 15 and 22 for Cycles 1 and 2, on Days 1 and 15 for Cycles 3-6, and Day 1 of each cycle for Cycle 7 and beyond for each 28-day cycle.
  • Cyclophosphamide, orally, at 400 mg on Days 1, 8, 15 of each 28-day cycle. In order to prevent myelotoxicity and bladder toxicity, cyclophosphamide will be discontinued after cycle 24.
  • Dexamethasone orally at 20 mg on day of daratumumab administration (pre-daratumumab) and 20 mg on the following day. On weeks without daratumumab administration, 40 mg dexamethasone weekly.
  • Pomalidomide, orally, at 4 mg on Days 1- 21 of each 28-day cycle.

In treatment ARM B, patients will receive daratumumab, cyclophosphamide, dexamethasone and pomalidomide as per the following schedule:

  • Daratumumab, IV, at 16 mg/kg on days 1, 8, 15 and 22 for Cycles 1 and 2, on Days 1 and 15 for Cycles 3-6, and Day 1 of each cycle for Cycle 7 and beyond for each 28-day cycle.
  • Cyclophosphamide, orally, at 400 mg on Days 1, 8 and 15 of each 28-day cycle. In order to prevent myelotoxicity and bladder toxicity, cyclophosphamide will be discontinued after cycle 24.
  • Dexamethasone at 20 mg orally on day of daratumumab administration (pre-daratumumab) and 20 mg on the following day. On weeks without daratumumab administration, 40mg dexamethasone weekly.
  • Pomalidomide, orally, added at first progression at 4 mg on Days 1- 21 of each 28-day cycle.

Individual subjects will remain on treatment as long as there is no evidence of disease progression or unacceptable toxicity or patient/physician decision to discontinue. Disease assessment as determined by the Site Investigator will be made according to the IMWG response criteria guidelines for MM.

Clinical Study Identifier: NCT03215524

Contact Investigators or Research Sites near you

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Nicole Laferriere, MD

Thunder Bay Regional Health Sciences Centre
Thunder Bay, ON Canada
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