Ibrutinib + Revlimid/Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen bySuzanne George, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Alliance Foundation Trials, LLC.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a combination of three drugs in patients whose multiple myeloma has returned or did not respond to previous treatments. The drugs work by blocking cancer cell growth, boosting the immune system, and reducing inflammation. The study aims to find the safest and most effective dose of these drugs.

Eligibility Criteria

This trial is for adults with relapsed/refractory multiple myeloma who have measurable disease, are in good physical condition (ECOG 0-1), and haven't progressed on high-dose lenalidomide. They must not have used ibrutinib or similar drugs before, be able to consent, follow the study plan, and provide samples for research. Pregnant women and those with certain health conditions are excluded.

Inclusion Criteria

Willingness to provide blood and tissue samples for correlative research purposes

I am 18 years old or older.

My condition worsened after my last treatment.

+13 more

Exclusion Criteria

I have an infection with HIV, HCV, or HBV.

You have had certain syndromes and disorders in the past.

I have a serious liver condition that is affecting me now.

+18 more

Participant Groups

The study tests a combination of Ibrutinib with Lenalidomide/Dexamethasone in men and women who've had at least one prior therapy for multiple myeloma. It's an open-label phase 1 trial where all participants receive the drug combo to evaluate its safety and effectiveness.

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

Dosage of the combination will depend on the determine of maximum tolerated dose learned from the Dose Escalation phase. Dose Expansion (Ibrutinib, Lenalidomide, Dexamethasone Combination)

Group II: Dose EscalationExperimental Treatment3 Interventions

Dose escalation will consist of three different drug levels of Ibrutinib, Lenalidomide, and Dexamethasone. Dose Escalation (Ibrutinib, Lenalidomide, Dexamethasone Combination)

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

🇪🇺 Approved in European Union as Dexamethasone for: