Trial · NCT04892264
Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma
NCT04892264, Phase 1, Terminated, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma. Trials, record NCT04892264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04892264
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma
- NCT number
- NCT04892264
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
Belantamab Mafodotin, Daratumumab, Dexamethasone, Lenalidomide, Quality-of-Life Assessment, Biospecimen Collection, Skeletal Survey X-Ray, Low Dose Computed Tomography of the Whole Body, Bone Marrow Aspiration, Bone Marrow Biopsy
- First posted
- 2021-05-19
- Last updated
- 2025-05-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of belantamab in combination with daratumumab and lenalidomide in patients with relapsed and/or refractory multiple myeloma (Phase I) | Up to 28 days | The MTD will be determined by the dose limiting toxicities (DLTs) seen in cycle 1 of the therapy in the phase I portion. The phase II portion will be based on the determined MTD. MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). |
| Primary | Complete response rate with belantamab, daratumumab, and lenalidomide, OR alternating cycles of daratumumab, lenalidomide, dexamethasone and belantamab, lenalidomide and dexamethasone, when used as initial therapy (Phase II) | After completion of induction therapy | A confirmed response is defined as a patient who has achieved a stringent complete response (sCR) or CR (as defined by the International Myeloma Working Group criteria) and maintained it on two consecutive evaluations at least 2 weeks apart. |
| Secondary | Incidence of toxicity (Phase I) | Up to 3 years | Defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. Non-hematologic toxicities will be evaluated via the ordinal Common Terminology Criteria (CTC) standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. |
| Secondary | Overall response rate | Up to 3 years | Will be estimated by the number of patients with each response category (e.g: sCR, CR, VGPR, partial response \[PR\], etc) divided by the total number of evaluable patients. |
| Secondary | Greater than or equal to very good partial response (VGPR) rate | Up to 3 years | Will be estimated by the number of patients with each response category (e.g: sCR, CR, VGPR, PR, etc) divided by the total number of evaluable patients. |
| Secondary | Progression-free survival | From registration to the earliest date of documentation of disease progression or relapse or death due to any cause, assessed up to 3 years | Will be estimated using the method of Kaplan-Meier. |
| Secondary | Time to response | Time between the date of first dose and the first documented evidence of a partial response or better, assessed up to 3 years | Descriptive statistics will be estimated. |
| Secondary | Incidence of adverse events | Up to 30 days post treatment | The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. |
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT04892264
GET https://conductscience.org/api/trials/v1/NCT04892264/registered