Daratumumab + Len/Dex shows ORR in relapsed/refractory multiple myeloma phase 1/2 trial
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Key Takeaway
Review phase 1/2 safety and ORR data for daratumumab combined with lenalidomide/dexamethasone in relapsed multiple myeloma.
This completed phase 1/2 study, sponsored by Janssen Research & Development, LLC, aimed to establish the safety profile of daratumumab in combination with lenalidomide and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma. The study enrolled 45 participants and was conducted in two parts. Part 1 was a dose escalation portion where participants were enrolled into cohorts at increasing dose levels of daratumumab in combination with lenalidomide and dexamethasone across 28-day treatment cycles. Part 2 was a cohort expansion portion designed to further explore the maximum tolerated dose (or the maximum tested dose) of daratumumab as determined in Part 1. The primary outcome measure for both Phase 1 and Phase 2 was the percentage of participants achieving an overall response rate. The study started on June 26, 2012, with primary completion on October 2, 2015, and results were posted on April 14, 2017. The abstract does not report specific numerical results for the overall response rate, safety data, or the determined maximum tolerated dose.
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View Original Abstract ↓
Status: COMPLETED | Phase: PHASE1/PHASE2
Condition(s): Multiple Myeloma
Intervention(s): Part 1 (Dose Escalation): Daratumumab (DRUG), Part 2 (Dose Expansion): Daratumumab (DRUG), Lenalidomide (DRUG), Dexamethasone (DRUG)
The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).
Detailed: The study is conducted in two parts. The dose escalation portion of the trial (Part 1) participants are enrolled into cohorts at increasing dose levels of daratumumab in combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.
Primary Outcome(s): Phase 1: Percentage of Participants With Overall Response Rate (ORR); Phase 2: Percentage of Participants With Overall Response Rate (ORR)
Enrollment: 45 (ACTUAL)
Lead Sponsor: Janssen Research & Development, LLC
Start: 2012-06-26 | Primary Completion: 2015-10-02
Results posted: 2017-04-14
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