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NCT05117008: EMBRACE

Maintenance Belantamab Mafodotin (Blenrep®) After B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-cell Therapy in Patients With Relapsed and/or Refractory Multiple Myeloma

Terminated Phase 2 Results posted Last updated 28 January 2025
What this trial tests

Phase 2 trial testing Belantamab mafodotin in Refractory Multiple Myeloma in 1 participant. Terminated before completion.

Timeline
19 July 2022
Primary endpoint
15 January 2024
15 January 2024

Quick facts

Lead sponsorMedical College of Wisconsin
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date19 July 2022
Primary completion15 January 2024
Estimated completion15 January 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical College of Wisconsin

Who can join

18 and older, any sex, with Refractory Multiple Myeloma or Relapse Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Patients With 12-month Progression-free Survival. Primary · 12 months

The primary endpoint of the study is the 12-month progression-free survival (PFS) with time counted from the CAR-T infusion conditional on being alive and progression-free at day +90 post CAR-T. An event will be defined as documented progression or death for any cause, subjects without an event will be censored at the last date known to be alive without progression.

GroupValue95% CI
Belantamab Mafodotin1

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Belantamab Mafodotin
Serious: 0/1 (0%)
Deaths: 0/1
Other adverse events (28 terms — click to expand)

ReactionSystemBelantamab Mafodotin
acquired torsion dystoniaMusculoskeletal and connective tissue disorders
AnemiaBlood and lymphatic system disorders
Back PainMusculoskeletal and connective tissue disorders
Blood lactate dehydrogenase increasedInvestigations
Blurred Vision, Right eyeEye disorders
Cervical dystoniaMusculoskeletal and connective tissue disorders
Cholesterol highInvestigations
Corn, Left plantat feetSkin and subcutaneous tissue disorders
Corneal Stromal scar, both eyesEye disorders
CoughRespiratory, thoracic and mediastinal disorders
DiarrheaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Corneal toxicitiesEye disorders
FeverGeneral disorders
Genital HerpesInfections and infestations
HeadacheNervous system disorders
HypertensionVascular disorders
HypophosphatemiaMetabolism and nutrition disorders
InfertilityReproductive system and breast disorders
Knee painGeneral disorders
Lung InfectionInfections and infestations
Lymphocyte count decreasedInvestigations
Nasal congestionRespiratory, thoracic and mediastinal disorders
Platelet count decreasedInvestigations
InsomniaPsychiatric disorders
Skin papillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
FatigueGeneral disorders
AnorexiaMetabolism and nutrition disorders

Data from ClinicalTrials.gov NCT05117008 adverse events section.

Sponsor's own description

This is a multicenter phase II, open-label study evaluating the efficacy and safety of belantamab mafodotin maintenance in participants with relapsed and/or refractory multiple myeloma (RRMM) who have received commercially available anti-BCMA CAR-T-cell therapy. Subjects will be enrolled 60-130 days after chimeric antigen receptor T-cell therapy (CAR-T) and receive belantamab mafodotin as maintenance therapy. Each maintenance cycle will have a duration of 56 days (+/- three days) and belantamab mafodotin will be administered at a dose of 2.5 mg/kg IV on day 1 of each cycle.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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
  2. Updates on CAR T cell therapy in multiple myeloma.
    Nasiri F, Asaadi Y, Mirzadeh F, Abdolahi S, et al · · 2024 · cited 10× · PMID 39261906 · DOI 10.1186/s40364-024-00634-5
  3. Targeting B Cell Maturation Antigen in Patients with Multiple Myeloma: Current Perspectives.
    Shrivastava T, Van Rhee F, Al Hadidi S. · · 2023 · cited 10× · PMID 37359353 · DOI 10.2147/ott.s370880
  4. Beyond BCMA: the next wave of CAR T cell therapy in multiple myeloma.
    Miller K, Hashmi H, Rajeeve S. · · 2024 · cited 8× · PMID 38800372 · DOI 10.3389/fonc.2024.1398902
  5. 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
  6. Race for the Cure: From the Oldest to the Newest Monoclonal Antibodies for Multiple Myeloma Treatment.
    Lapietra G, Fazio F, Petrucci MT. · · 2022 · cited 7× · PMID 36009041 · DOI 10.3390/biom12081146

Verify or expand the search:

Other trials of Belantamab mafodotin

Trials testing the same drug.

Other recruiting trials for Refractory Multiple Myeloma

Currently open trials in the same condition.

Other Medical College of Wisconsin trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05117008.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing