A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 (Belantamab Mafodotin) Administered in Combination with either Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed / Refractory Multiple Myeloma DREAMM6
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What's the purpose of this trial?

This trial is testing GSK2857916 (Belantamab Mafodotin) with two different of Standard of Care (SoC) regimens; Lenalidomide + Dexamethasone or Bortezomib + Dexamethasone. Researchers are testing which dose and schedule is the safest and works best to treat your cancer.

This trial is currently open and accepting patients.

What's being studied?

  • Belantamab Mafodotin (formerly GSK2857916) is an investigational product that acts as an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity (ADCC).
  • Bortezomib is a type of cancer drug called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments.
  • Lenalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

What will happen during the trial?

This trial is being run in two phases:

Part 1: Dose Escalation (Phase 1) - Researchers in this phase are trying to determine the highest dose of GSK2857916 that can be tolerated with the least side effects. Patients in this part of the trial will be assigned into two different arms and receive increasing doses of GSK2857916 in combination with Standard of Care drugs.

  • ARM A: GSK2857916, Lenalidomide and Dexamethasone
    • Patients will receive study drugs over a 28 day cycle, with GSK2857916 on day 1, Lenalidomide daily on days 1-21, and dexamethasone weekly. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
      • SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
      • SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
    • Once safety is established for a dose of GSK2857916, , a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients.
  • ARM B: GSK2857916, Bortezomib and Dexamethasone
    • Patients will receive study drugs over a 21 day cycle, with GSK2857916 on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
    • Once safety is established dose of GSK2857916, a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients. Note: Part 1 is closed for Arm B and Part 2 is Open.

Part 2: Dose Expansion (Phase 2) - Researchers in this part are testing the safety and effects of GSK2857916 in a larger group of patients. Patients in this part of the study will also be separated into two arms and each arm will receive GSK2857916 (as either a single or split dose) in combination with the Standard of Care drugs.

  • ARM A: GSK2857916, Lenalidomide and Dexamethasone
    • Patients will receive GSK2857916 as either a single or split dose with Lenalidomide daily on days 1-21, and Dexamethasone weekly in a 28 day cycle.
    • SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
    • SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
  • ARM B: GSK2857916, Bortezomib and Dexamethasone
    • Patients will receive GSK2857916 as either a single or split dose with Bortezomib and Dexamethasone in a 21-day cycle.
    • SINGLE DOSE- Patients will receive GSK2857916 (100% dose) on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.
    • SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.

The arm you’re assigned is determined by you and your doctor. However, this trial is non-randomized, and sequentially assigned, which means that the dose level and dosing schedule (single or split) you are placed in will be determined by when you join the study.

This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and the dose of the study drugs you are receiving.

During the first 4 doses of GSK2857916, you will also need to visit an opthalmologist (eye doctor) every 3 to weeks for eye examinations depending on your study arm. These visits may continue at the same frequency after the first 4 doses if you have certain side effects in your eyes; but if you don’t have side effects in your eyes, these exams can be reduced to once every 12 weeks.

You may be in the study as long as you are receiving benefit without intolerable side effects from treatment with GSK2857916, unless you decide to stop participating in the study or the study ends.

  • This trial is being run in two phases:

    Part 1: Dose Escalation (Phase 1) - Researchers in this phase are trying to determine the highest dose of GSK2857916 that can be tolerated with the least side effects. Patients in this part of the trial will be assigned into two different arms and receive increasing doses of GSK2857916 in combination with Standard of Care drugs.

    • ARM A: GSK2857916, Lenalidomide and Dexamethasone
      • Patients will receive study drugs over a 28 day cycle, with GSK2857916 on day 1, Lenalidomide daily on days 1-21, and dexamethasone weekly. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
        • SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
        • SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
      • Once safety is established for a dose of GSK2857916, , a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients.
    • ARM B: GSK2857916, Bortezomib and Dexamethasone
      • Patients will receive study drugs over a 21 day cycle, with GSK2857916 on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
      • Once safety is established dose of GSK2857916, a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients. Note: Part 1 is closed for Arm B and Part 2 is Open.

    Part 2: Dose Expansion (Phase 2) - Researchers in this part are testing the safety and effects of GSK2857916 in a larger group of patients. Patients in this part of the study will also be separated into two arms and each arm will receive GSK2857916 (as either a single or split dose) in combination with the Standard of Care drugs.

    • ARM A: GSK2857916, Lenalidomide and Dexamethasone
      • Patients will receive GSK2857916 as either a single or split dose with Lenalidomide daily on days 1-21, and Dexamethasone weekly in a 28 day cycle.
      • SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
      • SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
    • ARM B: GSK2857916, Bortezomib and Dexamethasone
      • Patients will receive GSK2857916 as either a single or split dose with Bortezomib and Dexamethasone in a 21-day cycle.
      • SINGLE DOSE- Patients will receive GSK2857916 (100% dose) on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.
      • SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.

    The arm you’re assigned is determined by you and your doctor. However, this trial is non-randomized, and sequentially assigned, which means that the dose level and dosing schedule (single or split) you are placed in will be determined by when you join the study.

    This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and the dose of the study drugs you are receiving.

    During the first 4 doses of GSK2857916, you will also need to visit an ophthalmologist (eye doctor) every 3 to weeks for eye examinations depending on your study arm. These visits may continue at the same frequency after the first 4 doses if you have certain side effects in your eyes; but if you don’t have side effects in your eyes, these exams can be reduced to once every 12 weeks.

    You may be in the study as long as you are receiving benefit without intolerable side effects from treatment with GSK2857916, unless you decide to stop participating in the study or the study ends.

See if you qualify

Additional Trial Information

Phase 1/2

Enrollment: 152 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

  • Have been diagnosed with relapsed/refractory multiple myeloma
  • Have already received an autologous stem cell transplant, or been told that you aren’t eligible for one
  • Have already received at least one line of therapy for your myeloma

Published Results

DREAMM-6 Data Set the Stage for Further Study of Belantamab Mafodotin–Based Triplet in Myeloma

December 05, 2020

For the 18 patients receiving 2.5 mg/kg of belamaf every 3 weeks with standard-of-care bortezomib and dexamethasone, there was an overall response rate (ORR) of 78% (95% CI, 52.4%-93.6%), with very good partial response in 9 patients (50%) and partial response in 5 patients (28%). Minimal response was observed in 1 patient and 3 patients (17%) had stable disease. There was also a clinical benefit rate of 83% (95% CI, 58.6%-96.4%). The median duration of response was not reached at a median of 18.2 weeks (range, 6.0-46.4) of treatment.

Of the patients with prior exposure to bortezomib, the ORR was 75%, and those with exposure to daratumumab (Darzalex) had an ORR of 67%; the clinical benefit rates were 81% and 67%, respectively.

Response rates increased for those treated in earlier lines of therapy. The ORR was 100% for patients treated in the second line compared with 50% for those who had received more than 3 prior lines of therapy.

All of the patients on the trial had treatment-related adverse events (AEs), although there were no new safety signals to date. Grade 3/4 AEs were seen in 16 patients (89%) and treatment-related serious AEs were seen in 5 (28%). No patients had any grade 5 AEs of interest. Serious AEs were reported in 67% and were considered related to treatment in 28%.

Read More
GSK gives taste of data on multiple myeloma drug ahead of ASCO

May 27, 2020

  • DREAMM-6 is testing belantamab mafodotin in combination with bortezomib and dexamethasone, in patients with relapsed or refractory myeloma who have received at least one prior therapy.
  • The data showed that the combination produced an overall response rate of 78% among 18 patients, including 50% who received a very good partial response and 28% who achieved a partial response.
  • After 18.2 weeks of treatment, the median duration of response had not yet been reached.
Read More

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, AZ

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Indiana

IU Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Michigan

Michigan State University (Breslin Cancer Center)

Lansing, MI

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

Nebraska

CHI Health Saint Francis Medical Center

Grand Island, NE

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

North Shore Hematology Oncology Associates, P.C

East Setauket, NY

Open and Accepting

South Carolina

Prisma Health Greenville Memorial Hospital

Greenville, SC

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

Mary Crowley Cancer Research Centers

Dallas, TX

Open and Accepting

Trial Resources

GSK Compassionate Use (Expanded Access) Request Portal

October 21, 2021

GSK recognises that there may be circumstances when it is appropriate for Healthcare Professionals to give their patients Investigational medicines to treat life threatening or seriously debilitating diseases/conditions where no satisfactory alternatives exist.

Learn more

Trial Links

Read the latest news and updates on this trial.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14, 2020

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Read more
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