The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Daratumumab (16 mg/kg) will be administered by IV infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants with creatinine clearance (CrCl) between 30 and 60 milliLitre (mL)/minute (min) will receive lenalidomide 10 mg every 24 hours.
Participants will receive dexamethasone 40 mg weekly, at day 1, 8, 15, 22 of each cycle.
Unnamed facility
Hiroshima, Japan
Unnamed facility
Kanazawa, Japan
Unnamed facility
Nagoya, Japan
Unnamed facility
Osaka, Japan
Unnamed facility
Shibuya City, Japan
Dose limiting toxicity (DLT) to analyze the safety of daratumumab when combined with lenalidomide and dexamethasone
Number of Participants With Dose Limiting Toxicity During Cycle 1.
Time frame: Cycle 1, Day 1 to Day 28
Rate of Complete Response (CR) or Better
CR is Defined as the proportion of Participants achieving CR (including stringent complete response \[sCR\]) according to the International Myeloma Working Group (IMWG) criteria.
Time frame: Approximately 3.7 years
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve CR, Partial Response (PR), VGPR, and sCR according to the IMWG criteria, during or after study treatment.
Time frame: Approximately 3.7 years
Very good partial response (VGPR) or better (VGPR, CR, or sCR)
VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (\>=) 90 pecent (%) reduction in serum M-protein plus urine M-protein level less than (\<) 100 milligram(mg)/24 hour (h).
Time frame: Approximately 3.7 years
Minimum Observed Serum Concentration (Cmin)
The Cmin is the minimum observed analyte concentration.
Time frame: Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose)
Maximum Observed Concentration (Cmax)
The Cmax is the maximum observed analyte concentration.
Time frame: Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose)
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Immunogenicity of daratumumab
Anti-daratumumab antibodies will be evaluated in serum samples collected for all the participants.
Time frame: Cycle 1, Cycle 3, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose)