IRD Regimen for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Millennium Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The main aim is to evaluate the effect of Ixazomib in combination with lenalidomide and dexamethasone on Multiple Myeloma disease progression at 2 years in participants who previously received a bortezomib-based induction regimen. The study will enroll approximately 160 participants, who are enrolled after completing 3 cycles of chemotherapy (Bortezomib-Based Induction Regimen). They are then treated with Ixazomib in addition to lenalidomide and dexamethasone.

Eligibility Criteria

This trial is for adults with Multiple Myeloma who've had a bortezomib-based treatment but no disease progression. They should be ineligible for transplant or not planning one within 24 months, able to perform daily activities (ECOG status 0-2), and agree to use effective contraception.

Inclusion Criteria

Must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.

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

I am a woman who cannot become pregnant or will use two birth control methods during the study.

+6 more

Exclusion Criteria

I do not have any uncontrolled heart problems.

I haven't taken specific strong medications or herbal supplements like St. John's wort in the last 14 days.

I haven't had any cancer besides nonmelanoma skin cancer or in situ carcinoma, or if I have, it was treated over 2 years ago with no remaining signs.

+10 more

Participant Groups

The study tests Ixazomib combined with Lenalidomide and Dexamethasone on patients who have completed prior chemotherapy. It aims to see how this combination affects the progression of Multiple Myeloma over two years in about 160 participants.

1Treatment groups

Experimental Treatment

Group I: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mgExperimental Treatment3 Interventions

Ixazomib 4 milligram (mg), capsules, orally, once, on Days 1, 8 and 15 and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22 of a 28-day cycle for a maximum of 39 cycles until PD or unacceptable toxicity, whichever occurs first for up to 3 years.

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

🇪🇺 Approved in European Union as Dexamethasone for: