Elo-Pom-Dex for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByRavi Vij, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT. Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.

Eligibility Criteria

This trial is for adults aged 18-75 with relapsed multiple myeloma after a first stem cell transplant. They must have failed 1 or 2 treatment lines, received specific induction therapy before a second transplant, and be responding to current treatment. Participants need proper organ function and can't join if they're pregnant, breastfeeding, have severe neuropathy, other active cancers or infections, heart issues, uncontrolled illnesses or are sensitive to the drugs tested.

Inclusion Criteria

I have been diagnosed with multiple myeloma through a tissue test.

I've had 2-6 rounds of initial treatment before my second stem cell transplant.

My blood tests and organ functions are within normal ranges.

My multiple myeloma relapsed after first-line stem cell transplant treatment.

I have tried 1 or 2 treatments for my multiple myeloma without success.

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

I am between 18 and 75 years old.

Exclusion Criteria

I am allergic to pomalidomide, dexamethasone, or components in elotuzumab.

I have had plasma cell leukemia or myeloma in my brain or spinal cord.

I am being treated for another cancer besides the one being studied.

I have severe nerve pain or numbness.

I am on dialysis.

I do not have any uncontrolled illnesses like heart problems or infections.

Participant Groups

The study tests whether adding Elotuzumab (a monoclonal antibody) to Pomalidomide (an immunomodulatory drug) and Dexamethasone (a steroid), known as Elo-Pom-Dex regimen, improves outcomes in patients receiving their second autologous stem cell transplantation for multiple myeloma.

1Treatment groups

Experimental Treatment

Group I: Elotuzumab + Pomalidomide + DexamethasoneExperimental Treatment3 Interventions

* Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study. * Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol. * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.