Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

NCT05091372 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0201NCI-2021-11334
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (1)

• Conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.

  through study completion, an average of 1 year

Study Arms (2)

Belantamab mafodotin

EXPERIMENTAL

belantamab mafodotin by vein over about 30 minutes on Day 1 of each cycle

Drug: Belantamab mafodotin

Lenalidomide

EXPERIMENTAL

lenalidomide by mouth every day of each cycle

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide dose levels: Dose level 0 (starting dose): Lenalidomide 10 mg/day PO continuously. Dose level -1: Lenalidomide 10 mg/day PO. One week off after every three weeks of treatment. Dose level -2: Lenalidomide 5 mg/day PO. One week off after every three weeks of treatment.

Also known as: CC-5013, Revlimid™

Lenalidomide

Belantamab mafodotin DRUG

Belantamab Mafodotin Belantamab mafodotin dose levels: Dose level -2 = 1.4 mg/kg IV every 12 weeks Dose level -1 = 1.9 mg/kg IV every 12 weeks Dose level 0 = 1.9 mg/kg IV every 8 weeks Cycles 1 - 6: All patients will start at dose level 0. Cycles 7 and onwards\*: Patients previously on dose level 0 (1.9 mg/kg IV every 8 weeks) will change to dose level -1 (1.9 mg/kg IV every 12 weeks) Patients previously on dose level -1 (1.9 mg/kg IV every 12 weeks) will continue at the same dose level. Patients previously on dose level -2 (1.4 mg/kg IV every 12 weeks) will continue at the same dose level. \*Reduction to a lower dose level is allowed in case of development of adverse effects or poor tolerance as determined by the treating physician.

Belantamab mafodotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed multiple myeloma status post 1st auto-HCT (day 60 - 180 post-transplant).
• Disease status (MRD positive or negative), partial response, or better.
• Age \> 18-year and 75-year. Non-English speaking patients are eligible.
• Karnofsky performance status 70 (Appendix A.).
• Adequate organ function (Please see Table 2. below). Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide.
• Patient agrees to enroll in the lenalidomide REMS program.
• Woman of child-bearing potential (WOCPB) must abstain from hetersosexual sexual contact or agrees to use 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), plus one additional effective method at least 28 days before starting therapy (for lenalidomide), during the intervention period, at least 28 days after the last dose of lenalidomide and at least 4 months after the last dose of belantamab mafodotin, 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.
• A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 10-14 days and also within 24 hours before the first dose of the study intervention.
• Nonchildbearing potential is defined as follows (by other than medical reasons):
• ≥ 45 years of age and has not had menses for \>1 year.
• Patients who have been amenorrhoeic for \<2 years without a history of a hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
• Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. 9. Male participant agrees to contraceptive use that should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies.
• Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:
• Refrain from donating sperm during treatment (including dose interruptions) and for 4 weeks after their last dose of lenalidomide.
• PLUS, either:

You may not qualify if:

• History of progressive disease at any time before starting maintenance.
• Patients with smoldering MM (IMWG criteria, Appendix F.).
• Patients with plasma cell leukemia.
• Patients with non-secretory MM (no measurable disease on electrophoresis and immunofixation). Patients with a measurable disease on PET scan or bone marrow will be eligible.
• Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia due to underlying liver disease (serum albumin \< 3gm/dL), esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria
• Current corneal or epithelial disease (except mild punctate keratopathy; see Appendix E.).
• Participant must not use contact lenses while participating in this study.
• Participant must not have used 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.
• Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
• Participant must not have had major surgery ≤ 4 weeks before initiating study treatment.
• The participant must not have any evidence of active mucosal or internal bleeding.
• Participant must not 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.
• Participant must not have an active infection requiring treatment.
• Participant must not have evidence of cardiovascular risk, including any of the following:
• Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77051, United States

RECRUITING

Related Publications (1)

• 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

Related Links

• M D Anderson Cancer Center

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

• Qaiser Bashir

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qaiser Bashir

CONTACT

(713) 794-4422; qbashir@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)