Quad Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byCaitlin Costello, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.

Research Team

Caitlin Costello, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for adults with Multiple Myeloma who've had 1-3 prior treatments but haven't used Daratumumab or Ixazomib before. They must not be pregnant, agree to birth control measures, and join the POMALYST REMS program. Participants should have a life expectancy over 3 months, an ECOG status of 0-2, and adequate organ function.

Inclusion Criteria

My liver is working well.

I agree to use two forms of birth control or abstain from sex for 120 days after the last dose.

I agree to take daily aspirin or, if I have a history of blood clots, to be on full anticoagulation treatment.

See 15 more

Exclusion Criteria

My condition did not improve after taking pomalidomide.

I have previously used daratumumab or ixazomib.

I am HIV positive or suspected to be.

See 17 more

Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)
Ixazomib (Proteasome Inhibitor)
Pomalidomide (Immunomodulatory Agent)

Trial OverviewThe study tests a combination therapy using Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in patients with relapsed/refractory Multiple Myeloma. It aims to evaluate the overall response rate to this salvage therapy regimen.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ixazomib, daratumumab, pomalidomide and dexamethasoneExperimental Treatment4 Interventions

Daratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15.