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Proteasome Inhibitor

Ixazomib + Lenalidomide for Multiple Myeloma

Phase 3

Waitlist Available

Led By Shaji K Kumar

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have been able to maintain at least 5mg daily dose of lenalidomide without growth factor support

Patient must be >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial compares lenalidomide alone to lenalidomide + ixazomib in treating patients with residual multiple myeloma after stem cell transplant.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include digestive issues that may affect absorption or tolerance of the drugs; nerve problems such as peripheral neuropathy; blood disorders affecting hemoglobin levels or platelet counts; liver function changes; fatigue; risk of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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

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My tests show remaining cancer cells or protein indicating cancer.

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I can have a bone marrow test after signing up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Multiple Myeloma

Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Trial Outcome Index (TOI) score

Overall survival (OS)

Secondary outcome measures

Best response on treatment

Change in FACT- General (G) score

Change in levels of all instruments

+7 more

Other outcome measures

ASK-12 scores

Adherence Starts with Knowledge (ASK)-12 scores

Cumulative dose

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (lenalidomide, ixazomib citrate)Experimental Treatment8 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 Group9 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib Citrate

2012

Completed Phase 2

~200

Lenalidomide

2005

Completed Phase 3

~1480

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1730

Bone Marrow Aspirate

2015

Completed Phase 3

~40

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,152 Total Patients Enrolled

578 Trials studying Multiple Myeloma

188,729 Patients Enrolled for Multiple Myeloma

Shaji K KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group

6 Previous Clinical Trials

1,738 Total Patients Enrolled

6 Trials studying Multiple Myeloma

1,738 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Clinical Trial 2023: Ixazomib Citrate Highlights & Side Effects. Trial Name: NCT03941860 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research facilities are coordinating this study?

"100 different medical centres are running this trial, with locations in cities such as Urbana, Warren and Bemidji. If you want to participate in the trial, try to choose a location close to you so that travelling is not too demanding."

Answered by AI

How is Ixazomib Citrate generally employed in medical care?

"Ixazomib Citrate is an effective treatment for multiple myeloma, as well as relapsed and/or refractory lymphoma, chronic lymphocytic leukemia, and patients that have undergone at least two rounds of systemic chemotherapy."

Answered by AI

Are there any positions available in this clinical trial for participants?

"The trial, which was first advertised on June 1st 2021, is still ongoing and looking for participants. The most recent update to the study was made on November 12th, 2022."

Answered by AI

How many individuals are being recruited for this experiment?

"Yes, this trial is still looking for patients. The most recent update on clinicaltrials.gov was on 11/12/2022, and the study needs 510 more participants from 100 different locations."

Answered by AI

What else is known about Ixazomib Citrate from a medical standpoint?

"Ixazomib Citrate was first researched in 2004 at the Saint Joseph Regional Medical Center. In the 16 years since then, 621 clinical trials have been completed with 323 more currently underway--many of which take place in Urbana, Michigan."

Answered by AI