Overview
Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2025-12-31
2025-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
Antibodies, Monoclonal
BB 1101
Daratumumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:- (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
Exclusion Criteria:
- 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