Belantamab Mafodotin + SoC for Multiple Myeloma

(DREAMM 9 Trial)

Not currently recruiting at 42 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments for individuals with newly diagnosed multiple myeloma, a type of blood cancer. The main goal is to assess the safety and effectiveness of belantamab mafodotin (an anti-BCMA antibody-drug conjugate) when combined with standard treatments like Velcade, Revlimid, and dexamethasone. Participants will join different groups to test varying doses and timing of these medications, aiming to identify the best approach for future studies. This trial may suit those recently diagnosed with multiple myeloma who are ineligible for high-dose chemotherapy with stem cell transplants due to other health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that belantamab mafodotin may help treat relapsed or refractory multiple myeloma, meaning it has been used in patients who did not respond to other treatments. In studies with 218 patients, about 24% continued the treatment for six months or more, suggesting it can be used for a significant duration. However, some side effects were noted, with the most common being eye-related issues, such as blurred vision and dry eyes.

Belantamab mafodotin is already approved by the FDA for treating certain types of multiple myeloma. This approval indicates that its safety is somewhat understood, but it does not eliminate all risks. Prospective trial participants should be aware that previous patients have managed the treatment, but should also be prepared for possible side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about belantamab mafodotin for multiple myeloma because it represents a novel approach compared to traditional treatments like bortezomib, lenalidomide, and dexamethasone. Unlike these standard therapies, belantamab mafodotin is an antibody-drug conjugate, which means it combines a targeted antibody with a potent anti-cancer drug, allowing it to directly attack cancer cells with precision. This targeted mechanism potentially reduces damage to healthy cells and might offer a new option for patients who have become resistant to standard treatments. Additionally, the varied dosing regimens being explored could allow for more personalized treatment strategies, optimizing effectiveness while minimizing side effects.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Studies have shown that belantamab mafodotin holds promise for treating multiple myeloma, particularly in patients who have tried other treatments. In a previous study, belantamab mafodotin achieved a 45% overall response rate, with nearly half of the patients experiencing tumor reduction or disappearance. In this trial, participants will receive belantamab mafodotin combined with bortezomib, lenalidomide, and dexamethasone (VRd/Rd) across various treatment arms. Another study found that belantamab mafodotin was more effective when combined with bortezomib and dexamethasone compared to some other treatments. The drug targets a protein called BCMA on cancer cells, enhancing the immune system's ability to fight the cancer. While most research has focused on patients whose cancer returned or did not respond to other treatments, these findings offer hope for newly diagnosed patients as well.26789

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
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
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
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
Group IV: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions
Group V: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/RdExperimental Treatment4 Interventions
Group VI: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Group VII: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions
Group VIII: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions
Group IX: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/RdExperimental Treatment4 Interventions
Group X: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/RdExperimental Treatment4 Interventions

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

🇺🇸
Approved in United States as Blenrep for:
🇪🇺
Approved in European Union as Blenrep for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
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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

Published Research Related to This Trial

Bortezomib, thalidomide, and lenalidomide significantly improve overall response and progression-free survival in multiple myeloma patients, with bortezomib uniquely showing a significant increase in overall survival compared to control treatments.
Common adverse events associated with these treatments include thrombosis/embolism, peripheral neuropathy, and the risk of second primary malignancies, highlighting the need for careful monitoring during therapy.
Efficacy and safety of bortezomib, thalidomide, and lenalidomide in multiple myeloma: An overview of systematic reviews with meta-analyses.Aguiar, PM., de Mendonça Lima, T., Colleoni, GWB., et al.[2022]
In the DREAMM-2 study involving 196 patients with relapsed or refractory multiple myeloma, belantamab mafodotin demonstrated anti-myeloma activity, with overall response rates of 31% in the 2.5 mg/kg cohort and 34% in the 3.4 mg/kg cohort.
The treatment had a manageable safety profile, with common grade 3-4 adverse events including keratopathy and thrombocytopenia, and only two treatment-related deaths, indicating that while there are risks, the benefits may outweigh them for patients with limited options.
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.Lonial, S., Lee, HC., Badros, A., et al.[2020]
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]

Citations

A real-world experience of efficacy and safety ...In summary, belantamab mafodotin appeared safe and relatively effective in this real-world heavily pretreated RRMM population, where the ...
Final Results of Phase 1 Clinical Trial of Belantamab ...In the DREAMM-7 study, Belamaf showed superior efficacy outcomes compared to daratumumab when combined with bortezomib and dexamethasone.
Belantamab mafodotin in patients with relapsed/refractory ...Belantamab mafodotin showed ORR 45%, PFS 3.8 months, and OS 17.2 months in relapsed/refractory multiple myeloma in a real-world setting. •. ORR was 29% in ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40348718/
Treatment Patterns, Efficacy, and Tolerability of ...Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis.
Targeting BCMA in relapsed and refractory multiple myelomaBelantamab mafodotin demonstrates significant efficacy with durable responses in RRMM, particularly in heavily pre-treated populations.
Blenrep (belantamab mafodotin-blmf) - accessdata.fda.govAmong the 218 patients, 24% were exposed for 6 months or longer. Relapsed or Refractory Multiple Myeloma. The safety of BLENREP as a single agent was evaluated ...
Real-World Effectiveness and Safety of Belantamab ...Belantamab mafodotin has been approved for patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) who have received ...
Blenrep approved by US FDA for use in treatment of ...Interim efficacy and safety data for Blenrep as a first line treatment are expected in early 2028 with enrolment expanded to US sites to ...
Belantamab mafodotin in patients with relapsed/refractory ...Belantamab mafodotin showed ORR 45%, PFS 3.8 months, and OS 17.2 months in relapsed/refractory multiple myeloma in a real-world setting. ORR was ...
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