118 Participants Needed

Belantamab Mafodotin + SoC for Multiple Myeloma

(DREAMM 9 Trial)

Recruiting at 39 trial locations
EG
UG
Overseen ByUS GSK Clinical Trials Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: GlaxoSmithKline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

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, it does mention that participants should not have had prior systemic therapy for multiple myeloma or smoldering multiple myeloma, except for a short emergency course of steroids or focal palliative radiation. It's best to discuss your current medications with the trial investigators to get a clear answer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to understand any potential interactions or requirements.

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

The available research does not provide specific data on the effectiveness of Belantamab Mafodotin + SoC for Multiple Myeloma. Instead, it discusses other treatments for multiple myeloma, such as the combination of thalidomide with melphalan and prednisone, which showed improved survival rates compared to melphalan and prednisone alone. Without direct data on Belantamab Mafodotin, we cannot conclude its effectiveness from the provided information.12345

What data supports the effectiveness of the drug Belantamab Mafodotin + SoC for Multiple Myeloma?

The research shows that lenalidomide combined with dexamethasone, which are part of the treatment, has been effective in treating multiple myeloma, especially in patients who have not responded to other treatments.12345

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

The provided research primarily discusses the safety profiles of lenalidomide, dexamethasone, and bortezomib, which are part of the standard of care (SoC) for multiple myeloma. Lenalidomide and dexamethasone have known adverse events such as hematological issues, fatigue, and pneumonia. Bortezomib is associated with peripheral neuropathy and myelosuppression. These adverse events are generally manageable with monitoring and dose adjustments. However, specific safety data for Belantamab Mafodotin in combination with these agents is not detailed in the provided research. Further investigation into studies specifically involving Belantamab Mafodotin would be necessary to obtain comprehensive safety data for this combination treatment.678910

What safety data exists for Belantamab Mafodotin + SoC for Multiple Myeloma?

The safety data for treatments like lenalidomide, dexamethasone, and bortezomib, which are part of the standard of care (SoC) for multiple myeloma, show that common side effects include blood-related issues, fatigue, and infections like pneumonia. These side effects are generally manageable with dose adjustments and monitoring.678910

Is the drug Belantamab Mafodotin a promising treatment for multiple myeloma?

Yes, Belantamab Mafodotin is a promising drug for multiple myeloma. It has shown deep and lasting responses in patients who have tried many other treatments before. It works by targeting specific cells in the body to fight the cancer, and it has been effective in clinical trials.1112131415

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 (ADC) that specifically targets the B cell maturation antigen (BCMA) on myeloma cells, delivering a toxic payload directly to them. This targeted approach allows it to be effective in patients who have already undergone multiple other treatments, offering a new option for those with relapsed or refractory multiple myeloma.1112141516

Research Team

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Adults over 18 with newly diagnosed multiple myeloma needing treatment, not eligible for stem cell transplant due to other health issues. They must have measurable disease, be able to perform daily activities (ECOG 0-2), and have proper organ function. Participants must use contraception and give informed consent. Excluded are those with active bleeding, liver disease, heart risks, infections requiring treatment, certain allergies or previous cancers (with exceptions), recent major surgery or therapy for multiple myeloma.

Inclusion Criteria

I am able to understand and sign the consent form.
I cannot undergo intense chemotherapy with stem cell transplant due to other health issues.
You must have a specific type of disease that can be measured according to certain guidelines.
See 4 more

Exclusion Criteria

You cannot tolerate or should not take medication to prevent viral infections.
I am at risk for heart disease.
I am considered fit for high dose chemotherapy with stem cell transplant.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belantamab mafodotin in combination with VRd for the first 8 cycles, followed by Rd from cycle 9 onwards. The dosing schedule varies by cohort.

Up to 52 months

End of Treatment

Participants complete an End of Treatment (EOT) visit at the point of study treatment discontinuation.

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a Safety Follow-up visit 70 days after EOT.

70 days

Treatment Details

Interventions

  • Belantamab mafodotin
  • Bortezomib
  • Dexamethasone
  • Lenalidomide
Trial Overview The trial tests Belantamab Mafodotin combined with standard drugs Bortezomib, Lenalidomide & Dexamethasone in adults with new multiple myeloma. The study will find the safest dose of Belantamab Mafodotin when given every 3-12 weeks alongside a regimen of the other drugs on specific cycles up to cycle 8 and then less frequently.
Participant Groups
10Treatment groups
Experimental Treatment
Group I: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group II: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group III: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group IV: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group V: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions
Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
Group VI: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
Group VII: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
Group VIII: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.
Group IX: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.
Group X: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.

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
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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

In a study of 16 patients with steroid-dependent and steroid-resistant minimal change disease, leflunomide combined with prednisone therapy led to a high remission rate, with 93.8% of patients achieving complete remission, including those who were previously steroid-resistant.
Leflunomide therapy significantly reduced the required dose of prednisone to maintain remission and decreased the relapse rate from 100% to 31.3%, demonstrating its efficacy and potential to improve treatment outcomes for patients with this condition.
Efficacy and safety of leflunomide in treatment of steroid-dependent and steroid-resistant adult onset minimal change disease.Zhou, J., Zhang, Y., Liu, G., et al.[2018]
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]
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

Efficacy and safety of leflunomide in treatment of steroid-dependent and steroid-resistant adult onset minimal change disease. [2018]
Addition of thalidomide to melphalan and prednisone treatment prolongs survival in multiple myeloma--a retrospective population based study of 1162 patients. [2013]
Lenalidomide plus dexamethasone vs. lenalidomide plus melphalan and prednisone: a retrospective study in newly diagnosed elderly myeloma. [2018]
A phase IIb trial of vorinostat in combination with lenalidomide and dexamethasone in patients with multiple myeloma refractory to previous lenalidomide-containing regimens. [2018]
Efficacy and safety of add-on tacrolimus versus leflunomide in rheumatoid arthritis patients with inadequate response to methotrexate. [2020]
How to maintain patients on long-term therapy: understanding the profile and kinetics of adverse events. [2018]
Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma. [2021]
An open-label, pharmacokinetic study of lenalidomide and dexamethasone therapy in previously untreated multiple myeloma (MM) patients with various degrees of renal impairment - validation of official dosing guidelines. [2021]
Efficacy and safety of bortezomib, thalidomide, and lenalidomide in multiple myeloma: An overview of systematic reviews with meta-analyses. [2022]
Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. [2021]
Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
"Real-life" data of the efficacy and safety of belantamab mafodotin in relapsed multiple myeloma-the Mayo Clinic experience. [2022]
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. [2020]
14.United Statespubmed.ncbi.nlm.nih.gov
DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. [2022]
Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. [2021]
16.United Statespubmed.ncbi.nlm.nih.gov
Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. [2022]