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

NCT05117008 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO00042276
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Multiple Myeloma; Relapse Multiple Myeloma

Keywords

CAR-T; Chimeric antigen receptor T-cell therapy; CAR Therapy

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With 12-month Progression-free Survival.

  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.

  12 months

Study Arms (1)

belantamab mafodotin

EXPERIMENTAL

Belantamab mafodotin is an intravenous drug.

Drug: Belantamab mafodotin

Interventions

Belantamab mafodotin DRUG

Belantamab mafodotin will be administered IV over approximately 30 minutes at the recommended dose of 2.5 mg/kg IV over 30 minutes on day 1 of every eight-week (+/- three days) cycle for a maximum of 12 cycles. Maintenance therapy with belantamab mafodotin will continue until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or end of study (maximum of 12 cycles), whichever occurs first.

Also known as: Blenrep

belantamab mafodotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of multiple myeloma with measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥200 mg/24 hour or involved serum-free light chain ≥10 mg/dL provided that the ratio of involved/uninvolved light chain is abnormal) prior to receiving CAR-T. Patients with no biochemically measurable disease before CAR-T may be enrolled if bidirectionally measurable plasmacytomas or bone marrow plasmacytomas \>10% are present prior to CAR-T infusion (sites must explicitly identify these patients to the Medical College of Wisconsin Multisite Team upon enrollment, as only four of these patients will be permitted on study, after which no future patients will be permitted to be enrolled).
• Received at least three prior therapies (including a PI, immunomodulatory drugs (IMiD), and anti-cluster of differentiation 38 antibody (anti-CD38 antibody) ) given before CAR-T, and has not progressed/relapsed after receiving CAR-T therapy.
• Achieved at least stable disease (SD) to CAR-T therapy and remained progression free after anti-BCMA CAR-T administration until enrollment (this requirement is also necessary prior administration of first study drug).
• Voluntary consent (per single Institutional Review Board (sIRB) requirements) must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Age ≥ 18 years.
• Life expectancy ≥ six months.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Creatinine clearance (CrCl) ≥ 30 mL/minute, either measured or calculated using a standard formula (e.g., Modification of Diet in Renal Disease (MDRD) Study equation; Cockcroft and Gault).
• Adequate hepatic function evidenced by aspartate aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 x ULN, bilirubin ≤ 1.5 x upper limit of the normal range (ULN) (isolated bilirubin ≥1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Adequate bone marrow function evidenced by hemoglobin ≥8 g/dL, platelets ≥75,000/mm3 (without transfusion of platelets in the prior seven days) and absolute neutrophil count ≥1,500/mm\^3 (growth factors are allowed during screening, but not within seven days prior to obtaining this result).
• Spot urine (albumin/creatinine ratio) \< 500 mg/g (56 mg/mmol) OR urine dipstick negative/trace (if ≥ 1+ only eligible if confirmed \< 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void).

You may not qualify if:

• Female participants:
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP). OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the intervention period and for four months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
• WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on cycle 1 day 1 (C1D1) and agree to use a highly effective method of contraception during the study and for four months after the last dose of belantamab mafodotin.
• Male participants:
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants are eligible to participate if they agree to the following from the time of first dose of study until six months after the last dose of belantamab mafodotin to allow for clearance of any altered sperm:
• Refrain from donating sperm.
• AND either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
• Must agree to use contraception/barrier as detailed below:
• Agree to use a male condom, even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as described in when having sexual intercourse with a WOCBP (including pregnant females).
• Prior disease refractoriness to belantamab mafodotin (progression on or within 60 days of enrollment.) This requirement is also necessary prior administration of first study drug).
• Prior use of belantamab mafodotin with discontinuation of therapy due to toxicity.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Meera Mohan MD, MS
• Organization: Medical College of Wisconsin

memohan@mcw.edu

414-805-4600

Study Officials

• Meera Mohan, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 11, 2021
• Study Start: July 19, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)