Combination Therapy for Multiple Myeloma

Palo Alto (17 mi)

Overseen byAshraf Badros, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Maryland, Baltimore

No Placebo Group

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

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

My side effects from previous treatments are mild, except for possible moderate nerve pain.

I have multiple myeloma and previous treatments, including specific antibodies and inhibitors, didn't work.

I am 18 years old or older.

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

I am HIV positive.

I am allergic to belantamab mafodotin, daratumumab, bortezomib, boron, mannitol, or similar drugs.

My liver condition is currently unstable.

I have had a stem cell transplant from a donor.

I have a heart condition.

I have symptoms of amyloidosis, POEMS syndrome, or plasma cell leukemia currently.

I have a mild eye surface condition, not severe.

I do not have active brain disease, blood cancer, or amyloidosis symptoms.

I am currently being treated for an infection.

I am currently experiencing active bleeding.

I haven't had myeloma treatment or plasmapheresis in the last 2 weeks.

I haven't taken high dose steroids in the last 14 days.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment1 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 AExperimental Treatment1 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: