Ixazomib + Lenalidomide for Multiple Myeloma

No longer recruiting at 257 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Must be taking: Lenalidomide

Must not be taking: Strong CYP3A inducers

Disqualifiers: Uncontrolled illness, Other malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Up to 10 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of two drugs, lenalidomide and ixazomib (also known as Ninlaro), is more effective than lenalidomide alone for people with multiple myeloma who still show signs of the disease after a stem cell transplant. Lenalidomide may slow down or shrink the cancer, while ixazomib might block cancer cell growth. Participants will join one of two groups: one taking both drugs and the other taking lenalidomide with a placebo. This trial targets individuals who have been taking lenalidomide after a stem cell transplant and still exhibit signs of multiple myeloma. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue taking lenalidomide as part of the study. You cannot be on other chemotherapy or investigational treatments, and certain medications like strong CYP3A inducers are not allowed within 14 days before starting ixazomib.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining ixazomib and lenalidomide has been studied for safety in people with multiple myeloma, a type of blood cancer. Studies have found that adding ixazomib to lenalidomide can extend the time before the cancer worsens. This combination has been tested in both controlled trials and real-world settings and is generally well-tolerated.

Common side effects include low blood counts, nausea, diarrhea, and fatigue. These are typical for cancer treatments and are usually manageable. Lenalidomide is already approved for treating multiple myeloma, indicating its safety is well-understood. Ixazomib is also used for multiple myeloma, adding further confidence in its safety.

Overall, current research suggests that these treatments together appear safe. However, discussing any concerns with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Unlike the standard treatments for multiple myeloma, which often include therapies like bortezomib or carfilzomib, the combination of ixazomib citrate and lenalidomide offers a new approach by incorporating an oral proteasome inhibitor, ixazomib. Most treatments require intravenous administration, but ixazomib is taken orally, making it more convenient for patients. This oral administration, combined with lenalidomide, not only simplifies the treatment regimen but also holds promise for maintaining efficacy while potentially reducing side effects associated with other proteasome inhibitors. Researchers are excited because this combination could improve patient quality of life by making treatment less intrusive without compromising effectiveness.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that using ixazomib with lenalidomide can help treat multiple myeloma. In this trial, participants in Arm A will receive the combination of ixazomib and lenalidomide. Studies have found that adding ixazomib to lenalidomide can prevent disease progression for over a year and a half. This combination has been tested in both clinical trials and real-life situations, showing good results for patients whose multiple myeloma has returned. Overall, evidence suggests that using both ixazomib and lenalidomide together may be more effective than using lenalidomide alone, which is what participants in Arm B will receive, to control the disease. ^{1 2 3 4 6}

Who Is on the Research Team?

Shaji K Kumar

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

Adults over 18 with multiple myeloma who have had a stem cell transplant within the last year and are on lenalidomide maintenance can join. They must show signs of residual cancer, be HIV-positive with undetectable viral load if applicable, and not have been off lenalidomide for more than 30 days. Participants need proper organ function, no severe illnesses or psychiatric conditions that could affect participation, and agree to birth control measures.

Inclusion Criteria

I have been on lenalidomide for 6-18 months after early stem cell transplant for my multiple myeloma.

I have been taking a daily dose of 5mg lenalidomide without needing additional medication to support my blood cell levels.

Your total bilirubin levels must be within a certain range, as tested within two weeks before the start of the study.

Exclusion Criteria

I don't have GI issues that affect my ability to take pills.

I am not currently on any experimental treatments or chemotherapy.

I am taking bisphosphonates for bone health while on this treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive lenalidomide and ixazomib or placebo in 28-day cycles

Up to 10 years

Monthly visits for treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

Every 3 months if <2 years from study entry, every 6 months if 2-5 years, annually if >5 years

What Are the Treatments Tested in This Trial?

Interventions

• Ixazomib Citrate
• Lenalidomide

Trial Overview The OPTIMUM trial is testing whether adding Ixazomib (or a placebo) to Lenalidomide treatment is more effective in patients with remaining signs of multiple myeloma after stem cell transplantation. The study involves bone marrow biopsies, imaging tests like CT and PET scans, blood tests, quality-of-life assessments through questionnaires, and biospecimen collection.

How Is the Trial Designed?

Group I: Arm A (lenalidomide, ixazomib citrate) Experimental Treatment 8 Interventions

Patients receive lenalidomide PO QD on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.

Group II: Arm B (lenalidomide, placebo) Placebo Group 9 Interventions

Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.

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

Approved in European Union as Ninlaro for:

• Multiple myeloma

Approved in United States as Ninlaro for:

• Multiple myeloma

Approved in Canada as Ninlaro for:

• Multiple myeloma

Approved in Japan as Ninlaro for:

• Multiple myeloma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8205687/

A comparison of the efficacy and safety of ixazomib ... Another study showed that ixazomib combined with DXMS can also achieve a good outcome in treating incipient MM; the ORR of patients could reach 71%, and the ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1516282

Oral Ixazomib, Lenalidomide, and Dexamethasone for ... The addition of ixazomib to a regimen of lenalidomide and dexamethasone was associated with significantly longer progression-free survival.

3. ninlaro.com ninlaro.com/clinical-studies

Results with NINLARO® (ixazomib) In the clinical study, people taking the NINLARO treatment combination went more than a year and a half (20.6 months) without their multiple myeloma getting ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03173092

NCT03173092 | A Study of Ixazomib (NINLARO®) in ... This study will look at the effectiveness and safety in participants who take the all-oral combination of ixazomib added to lenalidomide and dexamethasone.

5. ninlarohcp.com ninlarohcp.com/real-world-evidence

Real-World Evidence for the NINLARO® (ixazomib) Regimen The NINLARO® regimen has been investigated in patients with relapsed multiple myeloma in both randomized controlled trials and real-world studies.

6. ninlaro.com ninlaro.com/multiple-myeloma-journey

Navigating Multiple Myeloma - NINLARO® (ixazomib) For 1 out of 3 people with multiple myeloma, their multiple myeloma returns for the first time with no or minimal symptoms. If this is your experience, ...