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NCT02316106
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Phase 2 trial testing daratumumab in Multiple Myeloma in 123 participants. Completed in 3 June 2024.
2 June 2023
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 123 |
| Start date | 20 May 2015 |
| Primary completion | 2 June 2023 |
| Estimated completion | 3 June 2024 |
| Sites | 57 locations across France, Netherlands, Russia, United Kingdom, Germany, Israel, Canada, Australia |
Drugs / interventions tested
- daratumumab (daratumumab) — full drug profile →
- daratumumab (daratumumab) — full drug profile →
- daratumumab (daratumumab) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Monoclonal antibodies targeting CD38 in hematological malignancies and beyond.
van de Donk NW, Janmaat ML, Mutis T, Lammerts van Bueren JJ, et al · · 2016 · cited 268× · PMID 26864107 · DOI 10.1111/imr.12389 -
Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma.
Sanchez L, Wang Y, Siegel DS, Wang ML. · · 2016 · cited 127× · PMID 27363983 · DOI 10.1186/s13045-016-0283-0 -
Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).
Landgren CO, Chari A, Cohen YC, Spencer A, et al · · 2020 · cited 65× · PMID 32024950 · DOI 10.1038/s41375-020-0718-z -
A look backward and forward in the regulatory and treatment history of multiple myeloma: Approval of novel-novel agents, new drug development, and longer patient survival.
Kazandjian D, Landgren O. · · 2016 · cited 53× · PMID 28061986 · DOI 10.1053/j.seminoncol.2016.10.008 -
Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924 -
Evaluating Daratumumab in the Treatment of Multiple Myeloma: Safety, Efficacy and Place in Therapy.
Dima D, Dower J, Comenzo RL, Varga C. · · 2020 · cited 36× · PMID 32904669 · DOI 10.2147/cmar.s212526 -
Pursuing a Curative Approach in Multiple Myeloma: A Review of New Therapeutic Strategies.
D'Agostino M, Bertamini L, Oliva S, Boccadoro M, et al · · 2019 · cited 32× · PMID 31847174 · DOI 10.3390/cancers11122015 -
CD38 as Immunotherapeutic Target in Light Chain Amyloidosis and Multiple Myeloma-Association With Molecular Entities, Risk, Survival, and Mechanisms of Upfront Resistance.
Seckinger A, Hillengass J, Emde M, Beck S, et al · · 2018 · cited 32× · PMID 30079070 · DOI 10.3389/fimmu.2018.01676
Verify or expand the search:
- PubMed search for NCT02316106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of daratumumab
Trials testing the same drug.
- NCT04827979 — Daratumumab and Belatacept for Desensitization · Phase 1, PHASE2 · active not recruiting
- NCT04280328 — Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma · Phase 1 · completed
- NCT03068351 — Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced M · Phase 1 · completed
- NCT02841033 — Daratumumab for the Treatment of Patients With AL Amyloidosis · Phase 1, PHASE2 · completed
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
- NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
- NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
- NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
- NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02316106 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 27 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02316106.
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