Phase 2
Completed N=265
A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Source: ClinicalTrials.gov NCT03412565 ↗Enrolled (actual)
265
Serious AEs
40.8%
Results posted
Jan 2022
Primary outcomePrimary: D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) — 88.1; 90.8; 84.8 percentage of participants
Summary
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) |
88.1; 90.8; 84.8 | — |
| PRIMARY D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response |
71.6 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Daratumumab |
100; 98.6; 108; 137; 612; 648 | — |
| SECONDARY Percentage of Participants With Infusion-Related Reactions (IRRs) |
9.0; 9.0; 4.6; 4.5 | — |
| SECONDARY D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response |
77.6; 80.0; 77.3 | — |
| SECONDARY D-VRd Cohort: Overall Response Rate (ORR) |
97.0 | — |
| SECONDARY Percentage of Participants With CR or Better Response |
16.4; 55.2; 50.8; 42.4 | — |
| SECONDARY D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR) |
NA; NA; NA | — |
| SECONDARY Percentage of Participants With Anti-Daratumumab Antibodies |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Anti-rHuPH20 Antibodies |
6.1; 3.1; 4.8; 4.7 | — |
| SECONDARY D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate |
25.4; 21.5; 27.3 | — |
Eligibility 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:
- Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
- Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
- Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio
- Meets one of the sets of the following criteria:
- For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
- For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
- D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
- 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
- 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 1 second (FEV1) is less than ( )159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment
Data sourced from ClinicalTrials.gov (NCT03412565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.