Belantamab Mafodotin + SoC for Multiple Myeloma
(DREAMM 9 Trial)
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?
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Treatment Details
Interventions
- Belantamab mafodotin
- Bortezomib
- Dexamethasone
- Lenalidomide
Belantamab mafodotin is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma (approval withdrawn)
- Relapsed or refractory multiple myeloma
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School