Phase 2
N=123
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT02316106 ↗Enrolled (actual)
123
Serious AEs
31.2%
Results posted
Apr 2026
Primary outcome: Primary: Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria — 4.9; 12.2; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- daratumumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria |
4.9; 12.2; 0 | — |
| PRIMARY Progressive Disease or Death Rate |
0.096; 0.102; 0.109 | — |
| SECONDARY Minimal Residual Disease (MRD) Negative Rate |
2.4; 7.3; 0; 0; 0; 0 | — |
| SECONDARY Time to Next Treatment (TNT) for Active Myeloma |
NA; NA; 76.3 | — |
| SECONDARY Percentage of Participants Who Achieved Partial Response or Better Response (Stringent Complete Response [sCR] Plus Complete Response [CR] Plus Very Good Partial Response [VGPR] or a Partial Response [PR]) |
56.1; 56.1; 37.5 | — |
| SECONDARY Progression Free Survival (PFS) |
81.12; 84.44; 81.35 | — |
| SECONDARY Percentage of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features |
2.4; 0; 0; 19.5; 12.2; 9.8 | — |
| SECONDARY Number of Participants With Response to First Subsequent Multiple Myeloma Treatment |
6; 12; 15 | — |
| SECONDARY Overall Survival |
NA; NA; NA | — |
Summary
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
- Have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion Criteria
- Active multiple myeloma, requiring treatment as defined by the study protocol
- Primary systemic AL (immunoglobulin light chain) amyloidosis
- Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
- History of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
- Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
- Any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Data sourced from ClinicalTrials.gov (NCT02316106). 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.