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NCT05002816
Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma
Phase 1/Phase 2 trial testing Elotuzumab in Multiple Myeloma in 24 participants. Participants enrolled and being followed up; not accepting new ones.
22 January 2026
Quick facts
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 21 February 2022 |
| Primary completion | 22 January 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Elotuzumab (elotuzumab) — full drug profile →
- Belantamab mafodotin (BELANTAMAB MAFODOTIN) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Yale University
Who can join
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Maximum tolerated dose of elotuzumab in combination with belantamab mafodotin in subjects
Time frame: 28 days
Study patients will be enrolled and treated in cohorts of size 4 with maximum of 12 patients in the Phase I portion of the trial with possible dose de-escalation of belantamab mafodotin plus a fixed level of elotuzumab. Starting dose of belantamab mafodotin will be 1.9 mg/kg q4w. If the DLT rate hits de-escalation boundary (≥ 29.8%), four more patients will be enrolled for lower dose level with 1. -
Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: 28 days
DLT is defined as Grade 3 or greater febrile neutropenia lasting \>48 h despite adequate treatment, Grade 4 thrombocytopenia less than 25 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity (other than corneal events) which is more severe than expected for an individual agent or which does not resolve with appropriate supportive treatment within 48 hours
Sponsor's own description
The purpose of this research study is to determine if two drugs approved for treating multiple myeloma, belantamab mafodotin and elotuzumab, are safe and more effective when used together.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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"Find Me" and "Eat Me" signals: tools to drive phagocytic processes for modulating antitumor immunity.
Xiao L, Zhang L, Guo C, Xin Q, et al · · 2024 · cited 37× · PMID 38923737 · DOI 10.1002/cac2.12579 -
SLAMF7 as a Promising Immunotherapeutic Target in Multiple Myeloma Treatments.
Chu E, Wu J, Kang SS, Kang Y. · · 2023 · cited 28× · PMID 37754488 · DOI 10.3390/curroncol30090573 -
Retrospective analysis of the preparation and application of immunotherapy in cancer treatment (Review).
Lu J, Ding J, Liu Z, Chen T. · · 2022 · cited 14× · PMID 34981814 · DOI 10.3892/ijo.2022.5302 -
Belantamab Mafodotin: From Clinical Trials Data to Real-Life Experiences.
Morè S, Offidani M, Corvatta L, Petrucci MT, et al · · 2023 · cited 13× · PMID 37296910 · DOI 10.3390/cancers15112948 -
The Role of Belantamab Mafodotin, Selinexor, and Melflufen in Multiple Myeloma.
McCurdy A, Visram A. · · 2022 · cited 8× · PMID 36417082 · DOI 10.1007/s11899-022-00682-4 -
SLAMF receptors: key regulators of tumor progression and emerging targets for cancer immunotherapy.
Li J, Fan T, Wang D, Xiao C, et al · · 2025 · cited 2× · PMID 40382610 · DOI 10.1186/s12943-025-02308-8 -
Novel natural killer cell-based therapies for hematologic and solid malignancies: latest updates from ASCO 2024.
Gong X, Zhang L, He X, Yang J, et al · · 2024 · cited 2× · PMID 39075582 · DOI 10.1186/s13045-024-01575-0 -
Real world outcomes with elotuzumab-based therapies for patients with relapsed refractory multiple myeloma: a Mayo Clinic experience.
Parrondo RD, Das S, Sledge H, Bergsagel L, et al · · 2025 · PMID 40410136 · DOI 10.1038/s41408-025-01310-z
Verify or expand the search:
- PubMed search for NCT05002816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Elotuzumab
Trials testing the same drug.
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- NCT06232707 — A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapse · Phase 3 · withdrawn
- NCT06152575 — MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Ha · Phase 3 · recruiting
- NCT06208150 — A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamet · Phase 3 · recruiting
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 Yale University trials
Trials by the same sponsor.
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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 NCT05002816 (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 Yale University
- Last refreshed: 11 May 2026
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/NCT05002816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing