Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT01615029

Run by

Janssen Research & Development, LLC

People needed

45

Starts

2012-06-26

Expected to finish

2024-10-23

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex)
• (Part 2) Have received at least 1 prior line of therapy for multiple myeloma
• Be older than or be 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
• Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed

You may not qualify if…

• Have previously received an allogenic stem cell transplant
• Have received autologous stem cell transplant within 12 weeks before the first infusion
• Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion
• Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either, participants whose disease progresses within 60 days of lenalidomide, or participants whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an minimal response (MR) or development of progressive disease (PD) while on lenalidomide

Where it is running

• Study site — Boston, Massachusetts, United States
• Study site — Copenhagen Ø, Denmark
• Study site — Vejle, Denmark
• Study site — Lille, France
• Study site — Nantes, France
• Study site — Vandœuvre-lès-Nancy, France
• Study site — Utrecht, Netherlands
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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