Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant

NCT04876248 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: I 797720NCI-2021-02349
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Minimal residual disease (MRD) negative rate

  A 90% confidence interval about true 6-month post-consolidation MRD negative rate will be obtained.

  After 6 cycles of post-transplant consolidation with belantamab mafodotin and lenalidomide (1 cycle = 8 weeks)

Secondary Outcomes (3)

• Sustained MRD negative rate

  At 1 year after end of consolidation

• Progression-free survival

  Time from the start of consolidation therapy until disease progression death, due to disease, or last disease evaluation, assessed up to 5 years

• Overall survival

  Time from the start of consolidation until death due to any cause or last follow-up, assessed up to 5 years

Study Arms (1)

Treatment (belantamab mafodotin, lenalidomide)

EXPERIMENTAL

Patients receive belantamab mafodotin IV over 30 minutes on day 1 and lenalidomide PO QD on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.

Biological: Belantamab Mafodotin; Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (belantamab mafodotin, lenalidomide)

Belantamab Mafodotin BIOLOGICAL

Given IV

Also known as: Belantamab Mafodotin-blmf, Blenrep, GSK2857916, J6M0-mcMMAF

Treatment (belantamab mafodotin, lenalidomide)

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years of age at time of consent
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG), 2016 criteria, and
• Patient is considered transplant eligible, and
• Is not MRD negative complete response (CR) after high dose chemotherapy
• Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L (within 14 days of first dose of study treatment)
• Hemoglobin \>= 8.0 g/dL (within 14 days of first dose of study treatment)
• Platelets \>= 75 X 10\^9/L (within 14 days of first dose of study treatment)
• Total bilirubin =\< 1.5 X upper limit of normal (ULN) (isolated bilirubin \>= 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) (within 14 days of first dose of study treatment)
• Alanine aminotransferase (ALT) =\< 2.5 X ULN or \< 5 times ULN if documented liver infiltration (within 14 days of first dose of study treatment)
• Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ 1.73 m\^2 (within 14 days of first dose of study treatment)
• Spot urine (albumin/creatinine ratios (spot urine) \< 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) (within 14 days of first dose of study treatment)
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period

You may not qualify if:

• Evidence of active bleeding requiring intervention within the last four weeks prior to first dose of study treatment
• Current corneal epithelial disease except mild changes in corneal epithelium
• Any major surgery within the last four weeks of first dose of study treatment
• Use of contact lenses while participating in this study
• Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment
• Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Patients with isolated proteinuria resulting from MM are eligible
• Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with patient's safety or compliance to the study procedures
• Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if patient otherwise meets entry criteria
• 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
• Evidence of cardiovascular risk including any of the following:
• Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiography (EKG) abnormalities such as 2nd degree (type II) or 3rd degree atrioventricular (AV) block.
• History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within two months of first dose.
• Class III or IV heart failure as defined by the New York Heart Association functional classification system.
• Uncontrolled hypertension
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or lenalidomide

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (2)

• Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.

  PMID: 35285981 DERIVED

• Mohan M, Hari P, Szabo A, Dhakal B, Chhabra S, D'Souza A. Long term follow up of newly diagnosed multiple myeloma patients treated with pembrolizumab consolidation post-autologous stem cell transplantation. Leuk Res. 2021 Oct;109:106648. doi: 10.1016/j.leukres.2021.106648. Epub 2021 Jun 23. No abstract available.

  PMID: 34182226 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; Lenalidomide

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jens Hillengass

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: August 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)