Ixazomib + Lenalidomide + Dexamethasone for Smoldering Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: Lenalidomide

Must not be taking: Strong CYP3A inducers

Disqualifiers: Active MM, HIV, Hepatitis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This research study is evaluating a new drug called "ixazomib" as a possible treatment for Smoldering Multiple Myeloma.

Research Team

Irene Ghobrial, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with high-risk Smoldering Multiple Myeloma who can sign consent, are not pregnant, agree to birth control measures, and have no active major illnesses. Excluded are those with recent surgeries or other treatments, certain infections (HIV/HBV/HCV), another cancer within 2 years (with exceptions), known allergies to similar drugs, or any previous ixazomib treatment.

Inclusion Criteria

Your M protein level keeps getting higher.

My condition is high-risk smoldering multiple myeloma.

I am registered in the Revlimid REMS program.

See 4 more

Exclusion Criteria

Pregnant or nursing women

I experience significant numbness, weakness, or pain in my hands or feet.

I haven't taken any strong medication that affects liver enzymes within the last 14 days.

See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ixazomib, Lenalidomide, and Dexamethasone in cycles. Cycles 1-9 involve Ixazomib on days 1, 8, 15; Lenalidomide on days 1-21; Dexamethasone on days 1, 8, 15, 22. Cycles 10-24 involve Ixazomib on days 1, 8, 15 and Lenalidomide on days 1-21.

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Treatment Details

Interventions

Dexamethasone
Ixazomib
Lenalidomide

Trial Overview The study tests a new drug combo: Ixazomib with Lenalidomide and Dexamethasone in patients with Smoldering Multiple Myeloma. It aims to see if this combination can help manage the condition before it progresses further.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: IxazomibExperimental Treatment3 Interventions

* Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study

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