Multiple Myeloma
Conditions
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria - Measurable, secretory disease as defined by any of the following: a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b) Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or c) Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10mg/dL and abnormal FLC ratio - Meets one of the sets of the following criteria: a) For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP)regimen: newly diagnosed myeloma b) For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease - Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1,or 2 - During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug
Exclusion criteria
Exclusion criteria: - History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years - Exhibits clinical signs of meningeal involvement of MM - Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1second (FEV1) is less than ()159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy D-VMP, D-Kd and D-Rd Cohort: Overall Response Rate (ORR) 10 months after the last participant enrolled (up to 10months) efficacy D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate 10 months after the last participant enrolled (up to 10months) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics Maximum Observed Serum Concentrations (Cmax) of Daratumumab D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8 D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8 pharmacokinetics Minimum Observed Serum Concentrations (Cmin) of Daratumumab D-VRd: predose on Day 1 of Cycles 1, 3,and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12 safety Percentage of Participants with Infusion-Related Reactions (IRR) 10 months after the last participant enrolled (up to 10months) efficacy D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate 10 months after the last participant enrolled (up to 10months) efficacy D-VRd Cohort: Overall Response Rate (ORR) 10 months after the last participant enrolled (up to 10months) efficacy Complete Response or Better Rate 10 months after the last participant enrolled (up to 10months) efficacy Duration of Response (DOR) 10 months after the last participant enrolled (up to 10months) efficacy Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20) Up to 8 weeks after the last dose of study drug (approximately 1 year) efficacy D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative 10 months after the last participant enrolled (up to 10months) | — |
Countries
Europe, Japan, North America
Outcome results
None listed