Combination Therapy for Multiple Myeloma

Overseen By Sunita Sunita

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Must not be taking: High-dose steroids

Disqualifiers: Amyloidosis, CNS disease, Plasma cell leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma

Research Team

Ashraf Badros, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

This trial is for adults with Multiple Myeloma that's come back or hasn't responded to treatment. They must have tried at least three prior treatments, including specific anti-myeloma drugs, and not had certain stem cell transplants recently. Participants need good organ function, no active infections, and can't be pregnant or breastfeeding.

Inclusion Criteria

You have a certain amount of abnormal proteins in your blood or urine.

Provide signed written informed consent

I am using birth control as required by local laws for clinical study participants.

Exclusion Criteria

I am HIV positive.

I have been cancer-free from any other cancer for more than 2 years.

I have tested positive for hepatitis B recently.

Treatment Details

Interventions

• Belantamab Mafodotin
• Cyclophosphamide
• Dexamethasone

Trial Overview The study tests the effectiveness and safety of combining Belantamab Mafodotin with Cyclophosphamide and Dexamethasone in patients whose Multiple Myeloma has relapsed or is refractory. It aims to see how well this combination works as a treatment option.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles. 2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.

Group II: Arm A Experimental Treatment 1 Intervention

1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles. 2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.

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

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+