42 Participants Needed

Lenalidomide +/- Ixazomib + Dexamethasone for Multiple Myeloma

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Chicago
Must be taking: Lenalidomide
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effectiveness of lenalidomide alone to a combination of lenalidomide, ixazomib citrate, and dexamethasone in patients with multiple myeloma that persists after a stem cell transplant. The drugs help the immune system fight cancer, stop cancer cells from growing, and kill them. Lenalidomide, a derivative of thalidomide, has been shown to be effective in combination with dexamethasone for treating multiple myeloma.

Who Is on the Research Team?

Andrzej Jakubowiak, MD, PhD - UChicago ...

Andrzej Jakubowiak, MD, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for multiple myeloma patients with residual disease after a donor stem cell transplant. They must have been on lenalidomide maintenance for 3-4 months, have measurable residual disease, and proper organ function. Women of childbearing potential and men must agree to effective contraception methods. Exclusions include uncontrolled conditions like heart issues or diabetes, recent infections or surgeries, other cancer treatments within 30 days, certain drug allergies, severe neuropathy, CNS involvement, and QTc >470 msec.

Inclusion Criteria

I am currently taking lenalidomide and can handle a higher dose.
My condition has not worsened while on lenalidomide.
Your bilirubin levels must be within a certain range.
See 14 more

Exclusion Criteria

I haven't had radiotherapy in the last 14 days, or if it was a small area, in the last 7 days.
I do not have any serious health or mental conditions that could stop me from completing the treatment.
I haven't taken any antibiotics, antivirals, or antifungals in the last two weeks.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either lenalidomide alone or in combination with ixazomib citrate and dexamethasone for 12 courses, each lasting 28 days

12 months
Monthly visits for 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 years
Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Ixazomib Citrate
  • Lenalidomide
Trial Overview The study compares the effectiveness of lenalidomide alone versus in combination with ixazomib citrate and dexamethasone in treating remaining multiple myeloma post-transplant. Lenalidomide may boost the immune system's ability to kill cancer cells; ixazomib could interfere with cancer cell growth; dexamethasone aims to stop cancer spread.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ixazomib citrate, lenalidomide, dexamethasone)Experimental Treatment3 Interventions
Group II: Arm II (lenalidomide)Active Control1 Intervention

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

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Approved in European Union as Dexamethasone for:
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Approved in United States as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Multiple Myeloma Research Foundation

Collaborator

Trials
11
Recruited
3,600+
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