Daratumumab Combination for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byMuzaffar Qazilbash, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

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 whether daratumumab and hyaluronidase-fihj and pomalidomide work in treating patients with multiple myeloma that has come back (relapsed) after stem cell transplant. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as pomalidomide, 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. Giving daratumumab and hyaluronidase-fihj with pomalidomide may help control the disease in patients with relapsed multiple myeloma.

Eligibility Criteria

This trial is for patients with relapsed multiple myeloma post-stem cell transplant. They must have had a partial response to salvage therapy, be within 60-180 days post-transplant, and have an ECOG status of 0-2. Key eligibility includes adequate kidney function (creatinine <= 2.5 mg/dL), platelet count >= 50,000/mm^3, neutrophil count >= 1000/mm^3, liver enzymes up to three times the normal limit, and no uncontrolled heart arrhythmias.

Inclusion Criteria

Your liver enzyme levels are not more than three times the normal limit.

My condition worsened after initial treatment but improved with further therapy.

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

+7 more

Exclusion Criteria

I have not had radiotherapy in the last 14 days.

I am currently pregnant or breastfeeding.

I have tested positive for hepatitis B surface antigen or have resolved hepatitis B.

+14 more

Participant Groups

The study tests daratumumab with hyaluronidase-fihj and pomalidomide in treating relapsed multiple myeloma after stem cell transplant. Daratumumab is designed to stop cancer cells from growing by targeting specific proteins on their surface while pomalidomide aims to kill or halt the division of cancer cells.

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab)Experimental Treatment1 Intervention

Beginning 60-120 days after transplant, participants receive daratumumab IV over 4-8 hours on days 1, 8, 15 and 22 of courses 1 and 2 and days 1 and 15 of courses 3-6, then on day 1 of subsequent courses. Courses repeat every 28 days for 3 years 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