Daratumumab-Based Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byRachid C Baz, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase II study of daratumumab based therapies for older adults with multiple myeloma.

Eligibility Criteria

This trial is for older adults (65+) with newly diagnosed multiple myeloma who haven't had chemotherapy but may have had palliative radiotherapy or a small dose of dexamethasone. They must be able to follow the study schedule, use contraception if necessary, and have adequate organ function and bone marrow capacity. People with severe other illnesses, active infections requiring IV antibiotics, certain viral infections (HIV, hepatitis B/C), or uncontrolled medical conditions are excluded.

Inclusion Criteria

You have high levels of a protein called paraprotein in your blood or urine.

I am over 65 and have health issues that may worsen with intense chemotherapy.

My kidneys are functioning well enough, as per a specific test.

+9 more

Exclusion Criteria

You have tested positive for hepatitis C.

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

My only sign of plasma cell disorder is a single bone or soft tissue tumor.

+10 more

Participant Groups

The study tests daratumumab-based therapies combined with oral dexamethasone, lenalidomide pills, and bortezomib injections in treating multiple myeloma in older adults. It's designed to see how well patients respond to this combination therapy without undergoing high-dose chemotherapy with stem-cell transplantation due to their age or coexisting conditions.

3Treatment groups

Experimental Treatment

Group I: C: Daratumumab, Dexamethasone and BortezomibExperimental Treatment3 Interventions

Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle.

Group II: B: Daratumumab, Dexamethasone and LenalidomideExperimental Treatment3 Interventions

Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle.

Group III: A: Daratumumab & DexamethasoneExperimental Treatment2 Interventions

All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: