36 Participants Needed

Belantamab Mafodotin for Multiple Myeloma

(DREAMM12 Trial)

Recruiting at 25 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at initial diagnosis. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with RRMM, who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation ) and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal/mildly impaired renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD), where participants are either not undergoing or require hemodialysis. Participants will be administered belantamab mafodotin at a dose of 2.5 milligram per kilogram (mg/kg) intravenously once in three weeks (Q3W) dosing in Part 1. Based on the Part 1 Safety/Pharmacokinetic (PK) data, Part 2 participants will be administered the dose of either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose). Participants will be treated with belantamab mafodotin monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, follow-up phase and a post analysis continued treatment (PACT) phase . The total duration of the study is approximately up to 48 months.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received an investigational drug or a strong Organic-anion transporting polypeptide inhibitor within 14 days or 5 half-lives before the first dose of the study drug. It's best to discuss your current medications with the trial team.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain investigational drugs or strong inhibitors within a specific timeframe before the study. It's best to discuss your current medications with the study team to get a clear answer.

What data supports the idea that Belantamab Mafodotin for Multiple Myeloma is an effective drug?

The available research shows that Belantamab Mafodotin is effective for treating multiple myeloma, especially in patients who have already tried several other treatments. In the DREAMM-2 study, about 32% of patients who had been heavily pretreated showed a positive response to the drug. This means that nearly one-third of the patients experienced a reduction in their cancer after using Belantamab Mafodotin. Additionally, the drug has been approved in the USA and EU for patients who have tried at least four other therapies, indicating its effectiveness in difficult cases.12345

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

Belantamab mafodotin has shown effectiveness in treating relapsed or refractory multiple myeloma, with a 32% overall response rate in patients who had already undergone several treatments, as demonstrated in the DREAMM-2 study. It works by targeting and killing myeloma cells, and has been approved for use in patients who have tried at least four other therapies.12345

What safety data is available for Belantamab Mafodotin in treating multiple myeloma?

Belantamab Mafodotin has been evaluated in several studies, including the DREAMM-1 and DREAMM-2 trials, and has shown manageable safety in patients with relapsed/refractory multiple myeloma. Common adverse effects include ocular toxicity, such as keratopathy, blurred vision, and changes in visual acuity, with keratopathy being the most frequent. Thrombocytopenia and infections are also noted adverse effects. The FDA has approved it with a boxed warning for ocular toxicity, and it is available under a Risk Evaluation and Mitigation Strategy. Real-world studies confirm these findings, showing a tolerable toxicity profile similar to clinical trials.36789

Is Belantamab Mafodotin safe for humans?

Belantamab Mafodotin has been shown to have manageable safety in patients with multiple myeloma, but it can cause significant side effects, particularly eye-related issues like keratopathy (eye damage) and blurred vision. Other common side effects include low platelet counts (thrombocytopenia) and infections, and it is available only through a restricted program due to these risks.36789

Is the drug Belantamab Mafodotin a promising treatment for Multiple Myeloma?

Yes, Belantamab Mafodotin is a promising drug for treating Multiple Myeloma. It has shown strong anti-cancer effects in patients who have already tried several other treatments. It works by targeting and killing cancer cells, and it has been approved for use in the USA and EU for patients with relapsed or refractory Multiple Myeloma.12346

What makes the drug Belantamab Mafodotin unique for treating multiple myeloma?

Belantamab Mafodotin is unique because it is a first-in-class antibody-drug conjugate that targets BCMA on myeloma cells, delivering a powerful cancer-killing agent directly to the cells. This drug is specifically designed for patients who have already tried multiple other treatments, offering a new option for those with relapsed or refractory multiple myeloma.12346

Research Team

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for adults with multiple myeloma who've had at least 3 prior treatments (or 2 if they couldn't have a stem cell transplant) and have varying degrees of kidney function, including severe impairment or end-stage renal disease. Participants must be able to consent, follow study rules, and use contraception.

Inclusion Criteria

I am using birth control as required by local laws for clinical study participants.
I am at least 18 years old, or 19 if I am from the Republic of Korea.
Main additional inclusion criteria in Group 1 (matched control participants)
See 7 more

Exclusion Criteria

I haven't taken any experimental drugs within the last 14 days or 5 half-lives, whichever is shorter.
I have had a stem cell transplant from a donor.
I have not undergone plasmapheresis within the last week.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belantamab mafodotin monotherapy with dosing every 21 days until disease progression or other endpoints

Up to 48 months
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post Analysis Continued Treatment (PACT)

Participants may continue treatment based on analysis of safety and pharmacokinetic data

Long-term

Treatment Details

Interventions

  • Belantamab mafodotin
Trial OverviewThe trial tests belantamab mafodotin monotherapy in multiple myeloma patients with different levels of kidney health. It's given intravenously every three weeks. The study has two parts based on the severity of renal dysfunction and includes screening, treatment, follow-up, and continued treatment phases.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Part 2: Participants with ESRD (on hemodialysis)Experimental Treatment1 Intervention
Participants with ESRD (iGFR: \<15 mL/min) on hemodialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21-day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Group II: Part 2: Participants with ESRD (not on dialysis)Experimental Treatment1 Intervention
Participants with ESRD (iGFR: \<15 mL/min) not on dialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Group III: Part 1: Participants with severe renal impairmentExperimental Treatment1 Intervention
Participants with severely impaired renal function (iGFR: 15-29 mL/min) will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Group IV: Part 1: Participants with normal/mild impaired renal functionExperimental Treatment1 Intervention
Participants with normal or mildly impaired renal function (Normal: individual glomerular filtration rate \[iGFR\]: \>=90 milliliter per minute; Mild impairment: iGFR: 60-89 mL/min will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

Belantamab mafodotin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Blenrep for:
  • Relapsed or refractory multiple myeloma (approval withdrawn)
🇪🇺
Approved in European Union as Blenrep for:
  • Relapsed or refractory multiple myeloma

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Belantamab mafodotin (belamaf) is an approved treatment for adults with relapsed/refractory multiple myeloma, showing effectiveness by targeting BCMA and eliminating myeloma cells through multiple mechanisms.
The ongoing DREAMM-5 study is exploring the safety and efficacy of belamaf in combination with other novel therapies, which may enhance its anticancer effects compared to belamaf alone.
Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design.Nooka, AK., Weisel, K., van de Donk, NW., et al.[2021]
Belantamab mafodotin (belamaf) is an effective treatment for relapsed or refractory multiple myeloma, showing a 32% overall response rate in the phase II DREAMM-2 study with 95 patients.
While most patients experienced microcyst-like epithelial changes (MECs) as a side effect, these were generally manageable, with a high resolution rate and no permanent vision loss reported, indicating a need for careful monitoring and collaboration between eye care and oncology professionals.
Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.Farooq, AV., Degli Esposti, S., Popat, R., et al.[2020]
Belantamab mafodotin (belamaf) significantly improves overall survival (OS) and duration of response (DoR) in patients with relapsed/refractory multiple myeloma compared to selinexor plus low-dose dexamethasone, with a hazard ratio of 0.53 for OS and 0.41 for DoR, indicating its efficacy as a treatment option.
Belamaf also shows a favorable safety profile, with fewer severe adverse events compared to selinexor plus dexamethasone, making it a promising single-agent therapy for patients who have already undergone multiple lines of treatment.
DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma.Prawitz, T., Popat, R., Suvannasankha, A., et al.[2022]

References

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]
DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. [2022]
Belantamab Mafodotin: First Approval. [2021]
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. [2020]
Exposure-Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma. [2022]
Real-world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study. [2023]
FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. [2023]
Real-world study of the efficacy and safety of belantamab mafodotin (GSK2857916) in relapsed or refractory multiple myeloma based on data from the nominative ATU in France: the IFM 2020-04 study. [2023]