Elotuzumab + Lenalidomide for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen bySheeba Thomas, 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

Trial Summary

What is the purpose of this trial?This phase II trial studies how well elotuzumab works when given with lenalidomide as maintenance therapy after transplant in patients with newly diagnosed multiple myeloma who underwent transplant using their own stem cells (autologous transplant). Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following the initial treatment. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Adding elotuzumab to standard maintenance therapy with lenalidomide may work better in treating patients with multiple myeloma who have undergone transplant.

Eligibility Criteria

This trial is for patients with newly diagnosed multiple myeloma who have had a stem cell transplant using their own cells. Participants should be relatively healthy (ECOG status 0-2), able to follow contraception guidelines or abstain from sex, and must start the therapy within a certain time frame after transplant. They can't join if they've had major surgery or radiation recently, active hepatitis, infections needing IV antibiotics, allergies to study drugs, CNS involvement, trouble swallowing pills, are pregnant/lactating, or haven't recovered from previous treatments.

Inclusion Criteria

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

I changed my primary cancer treatment due to poor response or side effects, but haven't tried more than 2 treatments before stem cell transplant.

I had a stem cell transplant within 18 months after starting treatment for newly diagnosed myeloma.

+3 more

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I have active hepatitis B or C.

I still have mild or no side effects from my last chemotherapy.

+7 more

Participant Groups

The trial tests elotuzumab combined with lenalidomide as maintenance therapy post-autologous stem cell transplant in treating multiple myeloma. The goal is to see if this combination helps prevent cancer recurrence by enhancing the immune system's response and inhibiting cancer growth compared to standard treatment.

1Treatment groups

Experimental Treatment

Group I: Treatment (elotuzumab, lenalidomide)Experimental Treatment3 Interventions

Patients receive elotuzumab IV over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.