94 Participants Needed

Belantamab Mafodotin + Lenalidomide for Multiple Myeloma

QB
Overseen ByQaiser Bashir
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have used an investigational drug or certain anti-myeloma therapies within 14 days before starting the study, and you must not have received a monoclonal antibody treatment within 30 days before the study.

What data supports the effectiveness of the drug combination Belantamab Mafodotin and Lenalidomide for treating multiple myeloma?

The research shows that lenalidomide, when combined with other drugs like dexamethasone, has been effective in treating multiple myeloma, especially in elderly patients. This suggests that lenalidomide could be a beneficial component in combination therapies for multiple myeloma.12345

Is Belantamab Mafodotin + Lenalidomide safe for humans?

Belantamab Mafodotin has been associated with eye-related side effects, such as changes in vision and dry eyes, which are common and sometimes severe. It is only available through a special program due to these risks. Other side effects include low blood platelet levels and infections, but the safety profile is considered manageable with proper monitoring.678910

How is the drug Belantamab Mafodotin + Lenalidomide unique for treating multiple myeloma?

Belantamab Mafodotin is a first-in-class antibody-drug conjugate that targets B-cell maturation antigen (BCMA) on myeloma cells, delivering a powerful cancer-killing agent directly to the tumor. This approach is unique because it combines targeted therapy with a cytotoxic payload, offering a novel mechanism of action compared to traditional treatments for multiple myeloma.810111213

What is the purpose of this trial?

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.

Research Team

QB

Qaiser Bashir

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults aged 18-75 with newly diagnosed multiple myeloma who have had a stem cell transplant. They must be partially responsive to treatment, in good physical condition, and able to follow strict birth control guidelines. People with progressive disease, certain other myeloma types, eye diseases, recent major surgery or known allergies to the drugs can't join.

Inclusion Criteria

I cannot become pregnant due to my age or medical reasons.
I agree to use contraception or practice abstinence.
My organs are working well.
See 7 more

Exclusion Criteria

I have an active kidney condition.
You have tested positive for hepatitis C unless you meet specific criteria.
I have not had major surgery in the last 4 weeks.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belantamab mafodotin by vein on Day 1 and lenalidomide by mouth every day of each cycle for maintenance therapy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Belantamab Mafodotin
  • Lenalidomide
Trial Overview The study tests if adding Belantamab Mafodotin to Lenalidomide after a stem cell transplant helps patients achieve better outcomes by turning more MRD-positive cases into MRD-negative ones.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: LenalidomideExperimental Treatment1 Intervention
lenalidomide by mouth every day of each cycle
Group II: Belantamab mafodotinExperimental Treatment1 Intervention
belantamab mafodotin by vein over about 30 minutes on Day 1 of each cycle

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

In a study of 1162 multiple myeloma patients, those treated with the combination of thalidomide, melphalan, and prednisone (MPT) showed significantly better overall survival (OS) rates compared to those treated with melphalan and prednisone (MP) alone, with median OS of 4.2 years for MPT versus 2.2 years for MP in the first line of treatment.
The relative risk of death was reduced by 39% in the MPT group compared to the MP group in the first line of therapy, indicating that MPT is a more effective treatment option for multiple myeloma.
Addition of thalidomide to melphalan and prednisone treatment prolongs survival in multiple myeloma--a retrospective population based study of 1162 patients.Lund, J., Uttervall, K., Liwing, J., et al.[2013]
Mycophenolate mofetil (MMF) is commonly used to treat Membranous Glomerulonephropathy (MGN), but this case report highlights a rare side effect: acquired sensory-motor axonal polyneuropathy in a 66-year-old male patient.
This case is significant as it documents a previously unreported adverse effect of MMF, emphasizing the need for awareness of potential neurological complications in patients receiving this treatment.
Mycophenolate mofetil-induced peripheral neuropathy in the treatment of membranous glomerulonephropathy: A case report.Moghimi, M., Nekoukar, Z., Gholami, F.[2021]
In a study comparing lenalidomide-dexamethasone (len/dex) and melphalan-prednisone-lenalidomide (MPR) in 89 elderly patients with myeloma, both treatments showed similar efficacy in terms of time to progression, progression-free survival, and overall survival, indicating that either regimen can be effective for this patient group.
However, MPR was associated with significantly higher rates of severe hematologic toxicities, such as neutropenia and thrombocytopenia, suggesting that while both treatments are effective, len/dex may be a safer option with fewer severe side effects.
Lenalidomide plus dexamethasone vs. lenalidomide plus melphalan and prednisone: a retrospective study in newly diagnosed elderly myeloma.Gay, F., Vincent Rajkumar, S., Falco, P., et al.[2018]

References

Addition of thalidomide to melphalan and prednisone treatment prolongs survival in multiple myeloma--a retrospective population based study of 1162 patients. [2013]
Mycophenolate mofetil-induced peripheral neuropathy in the treatment of membranous glomerulonephropathy: A case report. [2021]
Lenalidomide plus dexamethasone vs. lenalidomide plus melphalan and prednisone: a retrospective study in newly diagnosed elderly myeloma. [2018]
Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial. [2020]
Efficacy and safety of add-on tacrolimus versus leflunomide in rheumatoid arthritis patients with inadequate response to methotrexate. [2020]
The role of belantamab mafodotin for patients with relapsed and/or refractory multiple myeloma. [2021]
FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. [2023]
DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. [2022]
Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. [2023]
Belantamab Mafodotin and Relapsed/Refractory Multiple Myeloma: This Is Not Game Over. [2021]
Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. [2021]
Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. [2020]
Belantamab Mafodotin: First Approval. [2021]
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