For people living with multiple myeloma—a blood cancer—one of the hardest moments is when the disease returns after treatment. This is called relapsed or relapsed-refractory myeloma. This study asked a direct question: is a new three-drug combination safe and does it work for these patients? The treatment combined daratumumab (a targeted antibody drug) with two existing drugs, lenalidomide and dexamethasone. The study was done in two parts. First, researchers carefully tested increasing doses of daratumumab to find the safest, highest dose to use. Then, they expanded the trial to further explore that dose. The main goal was to see how many patients responded to the treatment, which is measured by the Overall Response Rate. The study enrolled 45 patients to answer these questions. The findings from this trial help doctors understand if this specific combination is a viable option for people who have run out of other treatments, offering a potential new direction when the cancer comes back.
Can a new drug combination help people with multiple myeloma that has returned after treatment?
Plain Language Summary
What this means for you:
A three-drug combination was tested for safety and effectiveness in multiple myeloma that has returned. What this means for you:
A three-drug combination was tested for safety and effectiveness in multiple myeloma that has returned. 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