500 Participants NeededMy employer runs this trial

Belantamab Mafodotin or Daratumumab for Multiple Myeloma

(PrE1005 Trial)

MW
Overseen ByMichael Wright, MS
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: PrECOG, LLC.
Must be taking: Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatment combinations for individuals with newly diagnosed multiple myeloma, a type of blood cancer. The researchers aim to determine if belantamab mafodotin, a targeted therapy that delivers a cell-killing toxin directly to cancer cells, can improve outcomes compared to daratumumab, another treatment option. Ideal participants have not received a bone marrow transplant, may have declined it, and are experiencing symptoms of multiple myeloma, such as abnormal protein levels in the blood or urine. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

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

Research has shown that belantamab mafodotin, a targeted cancer treatment, is generally well-tolerated, though some side effects are common. It has proven effective in treating multiple myeloma, even for patients unresponsive to other treatments. However, one study found that eye problems affected 75% of patients, with about 33% experiencing more serious issues.

Eye-related side effects are the most reported but are usually manageable. Regular eye check-ups are important during this treatment. Despite these side effects, belantamab mafodotin has demonstrated a significant survival benefit for patients with multiple myeloma.

Daratumumab, another treatment option in the trial, is well-tolerated by many patients. The FDA has already approved it for treating multiple myeloma, indicating a strong safety profile. Common side effects include tiredness and nausea, but these are usually mild.

Both treatments offer promising options for managing multiple myeloma, with careful monitoring for 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 to targeting cancer cells. Unlike traditional therapies, Belantamab Mafodotin is an antibody-drug conjugate that delivers a toxic payload directly to the cancer cells, potentially reducing harm to healthy cells. This targeted action could lead to fewer side effects and more effective treatment outcomes. Meanwhile, Daratumumab, another treatment in the trial, is a monoclonal antibody that works by recruiting the immune system to attack and destroy multiple myeloma cells, offering a different mechanism of action compared to standard chemotherapy options.

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

Research has shown that belantamab mafodotin, which participants in this trial may receive, may effectively treat multiple myeloma. Specifically, studies reported that 66.7% of patients experienced a reduction or disappearance of their cancer. In this trial, belantamab mafodotin will be combined with other drugs like bortezomib and dexamethasone. Another group of participants will receive daratumumab, a well-known treatment that extends patient survival when combined with other therapies. Both treatments are effective against multiple myeloma, with belantamab mafodotin offering a new, targeted approach.678910

Who Is on the Research Team?

SK

Shaji Kumar, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed multiple myeloma who have not had more than one cycle of treatment and are either not eligible or choose to delay a bone marrow transplant. Participants must have measurable disease and be able to give informed consent.

Inclusion Criteria

I am able and willing to sign a consent form.
I am 18 years old or older.
I am able to care for myself, or my limited activity is only due to pain.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either belantamab mafodotin or daratumumab in combination with bortezomib, lenalidomide, and dexamethasone until disease progression, unacceptable side effects, or withdrawal of consent

Up to 86 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRD testing and patient-reported outcomes

Up to 70 days after the last dose of study medication

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 86 months

What Are the Treatments Tested in This Trial?

Interventions

  • Belantamab Mafodotin
  • Bortezomib
  • Daratumumab Hyaluronidase
  • Dexamethasone
  • Lenalidomide

Trial Overview

The study compares two drug combinations: one group gets belantamab mafodotin with bortezomib, lenalidomide, and dexamethasone; the other gets daratumumab hyaluronidase with the same three drugs. Treatment continues until the cancer worsens or side effects become too severe.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Belantamab MafodotinExperimental Treatment4 Interventions
Group II: Arm B:Active Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

PrECOG, LLC.

Lead Sponsor

Trials
19
Recruited
8,000+

GlaxoSmithKline

Industry 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

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Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

Real-world characteristics and outcomes of patients ... - PMC

In the overall cohort, the real-world progression-free survival and overall survival were 4.3 months (95% confidence interval [CI] 2.4–7.7) and ...

Efficacy and Safety of Belantamab Mafodotin with Bortezomib ...

belantamab mafodotin was … demonstrated an overall response rate (ORR) of 66.7% (95% CI, 51–80) across dose cohorts,

updated results. Belantamab mafodo2n (belamaf) i

“Real-Life” Data of the Efficacy and Safety of Belantamab Mafodotin in. Relapsed Multiple Myeloma- the Mayo Clinic Experience. Blood 138, 1639–1639 (2021). 5 ...

Belantamab Mafodotin Shows Real-World Efficacy in ...

Across all patients, the median progression-free survival (PFS) was 5 months (95% CI, 1-20), and the median OS was 12 months (95% CI, 3-28).

4751 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 shows significant overall survival ...

Belantamab Mafodotin shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse.

DREAMM-8 Study: Belantamab mafodotin plus pomalidomide ...

Adverse events (AEs) were reported in over 99% of patients in the BPd arm and 96% in the PVd arm, with ocular AEs being more common in the BPd ...

Belantamab Mafodotin: From Clinical Trials Data to Real-Life ...

Belantamab Mafodotin, a first-in-class anti-BCMA antibody–drug conjugate, demonstrated good efficacy and safety profile in triple-refractory patients

Longitudinal efficacy and safety modeling and simulation ...

MMAF‐containing ADCs, ocular adverse events were observed. To predict the effects of and safety end points and allowed for simulations with ...

The impact of dose modifications on safety and efficacy ...

In a retrospective study (N = 36), 75% of patients receiving belantamab mafodotin developed keratopathy of any grade and 33% developed Grade ≥3 ...