Trial · NCT05002816
Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma
NCT05002816, Phase 1, Phase 2, Active not recruiting, Yale University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma. Trials, record NCT05002816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05002816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma
- NCT number
- NCT05002816
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Yale University
- Conditions
- Multiple Myeloma
- Interventions
- Elotuzumab, Belantamab mafodotin
- First posted
- 2021-08-12
- Last updated
- 2026-05-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose of elotuzumab in combination with belantamab mafodotin in subjects | 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 1.9 mg/kg q8w; further dose reduction to 1.4mg/kg every 8 weeks will be planned for ongoing toxicity. Otherwise next cohort of 4 will be treated at same dose. The MTD will be determined once the maximum sample size of 12 for phase I portion is reached or stop the trial if 8 patients are treated at the initial dose without need of de-escalation. |
| Primary | Number of Participants who Experienced Dose-Limiting Toxicities (DLTs) | 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, any Grade 3 or greater non-hematologic laboratory value if the abnormality leads to hospitalization, grade 4 Keratopathy Visual Acuity (KVA) Scale, and liver toxicity meeting prespecified liver stopping criteria |
| Secondary | Preliminary evaluation of clinical efficacy/response rate | Every 28 day cycle until progression up to 2 years | Clinical efficacy and response rate will be determined by the MM labs and bone marrow biopsy . The options for overall response rate (ORR) will be: stable disease (SD) partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response (sCR) according to the 2016 International Myeloma Working Group (IMWG). Response evaluated with MM labs each cycle and bone marrow biopsy at C3D1. |
| Secondary | To evaluate progression free survival (PFS) | Followed for progression free survival until progression up to 2 years | To evaluate progression free survival (PFS), MM labs (SPEP, serum IFE, serum free light chains/ratio, immunoglobulins, UPEP/IFE) will be conducted every cycle to evaluate disease. Progressive disease will be assessed by standard IMWG response criteria. |
| Secondary | To evaluate overall survival (OS) | Followed until loss of follow-up, withdrawal of consent, death from any cause, or termination of study up to 2 years | To evaluate overall survival (OS), patients will be followed for overall survival under loss of follow-up, withdrawal of consent, death from any cause, or termination of study |
| Secondary | To evaluate minimal residual disease (MRD) by multi-parameter flow cytometry and by next-generation sequencing (NGS) | At follow-up visit (30 days +/-3 after discontinuation) | To evaluate minimal residual disease (MRD) by multi-parameter flow cytometry and by next-generation sequencing (NGS) via bone marrow biopsy at follow-up visit (30 days +/- 3 after discontinuation) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05002816
GET https://conductscience.org/api/trials/v1/NCT05002816/registered