Belantamab Mafodotin + SoC for Multiple Myeloma

(DREAMM 9 Trial)

Not currently recruiting at 42 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Disqualifiers: Smoldering multiple myeloma, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 52 months

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Who Is on the Research Team?

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.

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.

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?

Group I: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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/Rd Experimental Treatment 4 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

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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Thalidomide, lenalidomide, and bortezomib have significantly improved survival rates for patients with multiple myeloma, but they come with specific adverse event profiles that can impact treatment continuity.

Key adverse events include peripheral neuropathy (from thalidomide and bortezomib), venous thromboembolism (from thalidomide and lenalidomide), and myelosuppression (from lenalidomide and bortezomib), which are generally predictable and manageable with proper monitoring and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to maintain patients on long-term therapy: understanding the profile and kinetics of adverse events. Mateos, MV.[2018]

In a study evaluating lenalidomide and dexamethasone for multiple myeloma treatment in patients with renal impairment, it was found that those with moderate renal impairment may be under-dosed, while those with severe impairment showed decreased drug concentration after repeated doses, indicating the need for careful dose adjustments based on kidney function.

Despite these pharmacokinetic challenges, the treatment was deemed safe, as no patients discontinued lenalidomide due to toxicity, supporting its use in transplant-eligible patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chen, CI., Cao, Y., Trudel, S., et al.[2021]

Lenalidomide, in combination with dexamethasone, was administered to 1438 patients with relapsed or refractory multiple myeloma, showing a median treatment duration of 15.4 weeks and confirming its efficacy in this patient population.

The most common adverse events included hematological issues (49%), gastrointestinal problems (59%), and fatigue (55%), with serious adverse events like pneumonia occurring in 8% of patients, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. Chen, C., Reece, DE., Siegel, D., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a phase IIb study involving 25 lenalidomide-refractory multiple myeloma patients, the combination of vorinostat, lenalidomide, and dexamethasone showed an overall response rate of 24% and a clinical benefit rate of 80%, indicating significant activity in this challenging patient population.

The most common severe side effects included neutropenia (48%) and thrombocytopenia (32%), highlighting the need for careful monitoring of blood cell counts during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase IIb trial of vorinostat in combination with lenalidomide and dexamethasone in patients with multiple myeloma refractory to previous lenalidomide-containing regimens. Sanchez, L., Vesole, DH., Richter, JR., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 36 patients with multiple myeloma who had received a median of eight prior therapies, belantamab mafodotin demonstrated an overall response rate of 33%, which aligns with results from the DREAMM-2 trial.

Keratopathy was a notable side effect, affecting 43% of patients, with 8% discontinuing treatment due to this issue, highlighting the need for monitoring eye health during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Real-life" data of the efficacy and safety of belantamab mafodotin in relapsed multiple myeloma-the Mayo Clinic experience. Vaxman, I., Abeykoon, J., Dispenzieri, A., et al.[2022]

Lenalidomide monotherapy demonstrated efficacy in treating relapsed and refractory multiple myeloma, with a 26% response rate and median overall survival of 23.2 months among 222 patients studied.

The treatment was associated with manageable toxicities, primarily neutropenia and thrombocytopenia, suggesting that lenalidomide can be a safer alternative to combination therapies that include dexamethasone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma. Richardson, P., Jagannath, S., Hussein, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 24-week study involving 75 rheumatoid arthritis patients, tacrolimus (TAC) combined with methotrexate (MTX) was found to be non-inferior in efficacy compared to leflunomide (LEF) combined with MTX, indicating that TAC is an effective alternative treatment.

The safety profile of TAC was better than LEF, with fewer adverse events reported (49 in TAC group vs. 66 in LEF group), and lower instances of liver enzyme elevation (transaminitis) in the TAC group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of add-on tacrolimus versus leflunomide in rheumatoid arthritis patients with inadequate response to methotrexate. Shin, K., Baek, HJ., Kang, YM., et al.[2020]

In the DREAMM-2 study, after 13 months of follow-up, 32% of patients with relapsed or refractory multiple myeloma achieved an overall response to belantamab mafodotin (belamaf) at a dose of 2.5 mg/kg, indicating its efficacy in a heavily pretreated population.

The study found that belamaf maintained clinical activity without new safety concerns, even in patients experiencing prolonged dose delays due to corneal events, suggesting it is a safe treatment option for this patient group.

NCBI (Pubmed)

pubmed.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. Lonial, S., Lee, HC., Badros, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

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In summary, belantamab mafodotin appeared safe and relatively effective in this real-world heavily pretreated RRMM population, where the ...

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In the DREAMM-7 study, Belamaf showed superior efficacy outcomes compared to daratumumab when combined with bortezomib and dexamethasone.

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sciencedirect.com/science/article/pii/S295032802500038X

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 ...

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Belantamab mafodotin demonstrates significant efficacy with durable responses in RRMM, particularly in heavily pre-treated populations.

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accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf

Blenrep (belantamab mafodotin-blmf) - accessdata.fda.gov

Among 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 ...

7.

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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 ...

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Interim efficacy and safety data for Blenrep as a first line treatment are expected in early 2028 with enrolment expanded to US sites to ...

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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 ...