Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma

NCT05065047 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 2020-1059NCI-2021-09412
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT). The safety of this drug after transplant will also be studied

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

  through study completion, an average of 1 year

Study Arms (1)

Belantamab mafodotin

EXPERIMENTAL

belantamab mafodotin by vein over 30 minutes every 8 weeks

Drug: Belantamab mafodotin

Interventions

Belantamab mafodotin DRUG

Given by IV

Belantamab mafodotin

Eligibility Criteria

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

You may qualify if:

• Patients with relapsed or refractory multiple myeloma. Eligible patients will be enrolled in the protocol no less than 60 days and must be initiated no longer than 180 days (± 2 weeks) post ASCT. Patient's transplant may be either transplantation naïve or with a history of previous autologous transplant.
• Patients who have had two or more lines of therapy consisting of at least one of three agents including a proteasome inhibitor or an immunomodulatory agent or an anti-CD38 targeting therapy.
• Note:
• a) Induction therapy, autologous stem cell transplantation (ASCT) \& maintenance therapy if given sequentially without intervening progressive disease (PD) are considered one line of therapy. b) Refractory MM may be defined as disease that is refractory to treatment while on therapy or that shows progression within 60 days of the last therapy.
• Disease status, partial response, or better.
• Age ≥ 18-year and ≤ 75-year. English and non-English speaking patients are eligible.
• Platelet count ≥ 50,000/mm3 \& Hemoglobin ≥ 8 g/dL, ANC ≥ 1.0 × 109/L
• Karnofsky Performance Status (KPS) \>70 (Appendix B.).
• Adequate organ function (ALT ≤ 2.5 ULN; Total bilirubin ≤ 1.5 ULN or total bilirubin
• ULN with direct bilirubin ≤ 35%; estimated glomerular filtration rate ≥30 mL/min per 1.73 m2
• Participants must not be pregnant or lactating
• Female participants: contraceptive use should be consistent with institutional guidelines 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 (as described in Appendix C.), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention.

You may not qualify if:

• \. Current corneal epithelial disease (except mild punctate keratopathy). 2. Participant must not use contact lenses while participating in this study. 3. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. 4. Participants who are using an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
• \. Participants who have had major surgery ≤ 4 weeks before initiating study treatment.
• \. Participants who have any evidence of active mucosal or internal bleeding. 10. Participants who have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
• \. Participants who have an active infection requiring treatment 12. Participants who have evidence of cardiovascular risk, including any of the following:
• a) Evidence of current clinically significant uncontrolled and/or untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
• b) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
• c) Class III or IV heart failure as defined by the New York Heart Association functional classification system.
• d) Uncontrolled hypertension. 13. Participants who have known HIV infection, unless the participant can meet all of the following criteria:
• Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL
• CD4+ T-cell (CD4+) counts ≥350 cells/uL
• No history of AIDS-defining opportunistic infections within the last 12 months 14. Participant must not have presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
• \. Participant must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
• Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
• Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
• \. Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

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

Study Officials

• Neeraj Saini, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: October 1, 2021
• Study Start: January 5, 2023
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)