Daratumumab for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen by Sikander Ailawadhi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Eligibility Criteria

This trial is for transplant-eligible patients with multiple myeloma who have had prior therapy but not daratumumab. They must show measurable cancer markers, be in decent physical condition (ECOG 0-2), and have adequate organ function. Pregnant or breastfeeding women, those unwilling to use contraception, or individuals with certain medical conditions like severe infections, heart issues, or other cancers are excluded.

Inclusion Criteria

My multiple myeloma is measurable by specific medical criteria.

I can take care of myself and am up and about more than half of my waking hours.

My white blood cell count is healthy without needing medication.

Exclusion Criteria

I have previously been treated with daratumumab.

I have not needed IV antibiotics for an infection in the last 14 days.

Pregnant women

Participant Groups

The study is testing the effectiveness of daratumumab in treating multiple myeloma in patients eligible for a stem cell transplant. Daratumumab is an antibody that targets cancer cells to prevent their growth. The trial includes autologous hematopoietic stem cell transplantation and lenalidomide as part of the treatment process.

Group I: Treatment (daratumumab, ASCT, lenalidomide) Experimental Treatment 3 Interventions

CONSOLIDATION I: Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION II: Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. MAINTENANCE: Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Darzalex for:

• Relapsed and refractory multiple myeloma
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

🇺🇸 Approved in United States as Darzalex for:

• Multiple myeloma in patients who have received at least three prior therapies
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
• Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Florida Jacksonville, FL

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

National Cancer Institute (NCI) Collaborator

References