Daratumumab-Based Regimens for Multiple Myeloma
(DeRIVE Trial)

Recruiting in Palo Alto (17 mi)

Ajay K. Nooka, MD, MPH, FACP | Winship ...

Overseen byAjay K. Nooka, MD,MPH,FACP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well daratumumab, ixazomib, and dexamethasone with or without bortezomib work in treating patients with newly diagnosed multiple myeloma. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as ixazomib, dexamethasone, and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving daratumumab, ixazomib, and dexamethasone with or without bortezomib may work better in treating patients with multiple myeloma.

Eligibility Criteria

This trial is for adults with newly diagnosed multiple myeloma who are in good physical condition (ECOG PS 0-1) and have measurable disease. They can't have had certain other conditions or treatments, must agree to contraception if applicable, and be willing to follow the study rules. Pregnant women, those with allergies to study drugs, or patients treated previously with similar drugs are excluded.

Inclusion Criteria

I agree to use contraception as required.

I am fully active or restricted in physically strenuous activity but can do light work.

You have a certain level of M-protein in your blood or urine that can be measured.

See 8 more

Exclusion Criteria

I haven't taken strong CYP3A inducers or St. John's wort recently.

I am allergic or react badly to dexamethasone, boron, mannitol, or similar drugs.

I have been treated with anti-CD38 therapy before.

See 17 more

Treatment Details

Interventions

Bortezomib (Proteasome Inhibitor)
Daratumumab (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)
Ixazomib (Proteasome Inhibitor)

Trial OverviewThe trial is testing a combination of daratumumab, ixazomib, and dexamethasone against the same combo plus bortezomib in treating new multiple myeloma cases. It aims to see which regimen is more effective at stopping cancer growth by comparing these two treatment groups.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm II (DVd, DId)Experimental Treatment4 Interventions

INDUCTION CYCLES 1-3: Patients receive dexamethasone IV and PO on days 1, 8, and 15, daratumumab IV on days 1, 8, and 15, and bortezomib subcutaneously (SC) on days 1, 4, 8, and 11. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. INDUCTION CYCLES 4-8: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on days 1 and 15, and ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo stem cell transplant per standard of care. Patients who have at least stable disease after induction and patients who have undergone transplant continue to Maintenance. MAINTENANCE: Patients receive dexamethasone IV on day 1, daratumumab IV on day 1, and ixazomib PO on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (DId)Experimental Treatment3 Interventions

INDUCTION: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2 and on days 1 and 15 of cycles 3-8, and ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo stem cell transplant per standard of care. Patients who have at least stable disease after induction and patients who have undergone transplant continue to Maintenance. MAINTENANCE: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on day 1, and ixazomib PO on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Velcade for: