Drug Combination for Relapsed Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byAndrew Yee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.

Eligibility Criteria

This trial is for adults over 18 with relapsed Multiple Myeloma who have had at least one prior therapy including lenalidomide and a proteasome inhibitor. Participants must have measurable disease indicators, such as specific levels of monoclonal protein in blood or urine, and be physically able to perform daily activities (ECOG ≤ 2).

Inclusion Criteria

My white blood cell count is healthy and I haven't used G-CSF recently.

I have had treatment for my multiple myeloma that came back or didn't respond to treatment.

I can take care of myself and am up and about more than 50% of my waking hours.

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Exclusion Criteria

Participants who are receiving any other investigational agents

I am not on high dose corticosteroids, except for certain conditions.

Pregnant or lactating females

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Treatment Details

Interventions

Bortezomib (Anti-tumor antibiotic)
Dexamethasone (Corticosteroid)
Elotuzumab (Monoclonal Antibodies)
Pomalidomide (Anti-metabolites)

Trial OverviewThe study tests a combination treatment for Multiple Myeloma using Elotuzumab, Pomalidomide, Bortezomib, and Dexamethasone. It aims to find out how effective this drug mix is for those whose cancer has returned after previous treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Elotuzumab, pomalidomide, bortezomib, dexExperimental Treatment4 Interventions

Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.

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

🇪🇺 Approved in European Union as Velcade for: