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Ixazomib + Lenalidomide Maintenance Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Leona Holmberg

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2

Calculated creatinine clearance >= 30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median 4.6 years from start of therapy

Awards & highlights

Study Summary

This trial is testing if ixazomib citrate & lenalidomide, given as maintenance therapy after stem cell transplant, can prolong the time until cancer returns.

Who is the study for?

This trial is for multiple myeloma patients who've had a stem cell transplant using high dose melphalan therapy. They should be within 30-120 days post-transplant, recovered from acute toxicity, and have an ECOG performance status of 0-2. Participants must not be pregnant or breastfeeding, agree to contraception if of childbearing potential, and have adequate organ function. Exclusions include active infections, recent major surgery or radiotherapy, uncontrolled heart conditions, known allergies to study drugs or their components (including boron), certain prior cancers within 2 years except nonmelanoma skin cancer with complete resection.Check my eligibility

What is being tested?

The phase II trial tests alternating ixazomib citrate with lenalidomide as maintenance therapy after stem cell transplant in multiple myeloma patients. Ixazomib may block enzymes needed for cancer growth while lenalidomide might stimulate the immune system against cancer cells. The goal is to extend the time before the cancer returns.See study design

What are the potential side effects?

Potential side effects can include digestive issues that affect oral drug absorption or tolerance; allergic reactions including those to boron; peripheral neuropathy (nerve damage) which could cause pain; and possible interactions with other medications affecting liver enzymes like CYP1A2 and CYP3A.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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My kidneys are functioning well enough to clear waste.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median 4.6 years from start of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median 4.6 years from start of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and median 4.6 years from start of therapy for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With Adverse Events, Graded According to CTCAE Version 4.0

Secondary outcome measures

Disease Free Survival

Overall Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib citrate and lenalidomide)Experimental Treatment3 Interventions

Within 30-120 days after finishing autologous transplant, patients receive ixazomib citrate PO on days 1, 8 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-28. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients will continue to alternate between ixazomib citrate and lenalidomide every 2 courses for up to 24 months in the absence of disease progression or unacceptable toxicity.

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,215 Total Patients Enrolled

64 Trials studying Multiple Myeloma

2,944 Patients Enrolled for Multiple Myeloma

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,186 Total Patients Enrolled

66 Trials studying Multiple Myeloma

3,765 Patients Enrolled for Multiple Myeloma

Leona HolmbergPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

11 Previous Clinical Trials

349 Total Patients Enrolled

5 Trials studying Multiple Myeloma

178 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Are new participants being accepted for this trial at present?

"Currently, this medical experiment is not seeking additional patients. Initially posted on December 30th 2015 and last updated July 12th 2022, it has now ceased recruitment. However, there are 818 trials actively recruiting participants with neoplasms and plasma cell disorders as well as 317 trials for Ixazomib Citrate that remain open to new enrollees."

Answered by AI

What other experiments have utilized Ixazomib Citrate for its therapeutic potential?

"Currently, there are 317 clinical trials globally exploring the potential of Ixazomib Citrate. 59 such experiments are currently in Phase 3 while Chicago, Illinois stands out as a hub for these studies with 14323 locations providing related treatments."

Answered by AI

What is the number of participants in this experiment?

"As of July 12th 2022, this clinical trial has ceased recruiting participants. Initially posted on December 30th 2015, it is no longer an available option for those seeking medical studies to join. However, 818 trials are currently enrolling individuals with neoplasms and plasma cell while 317 offer the drug Ixazomib Citrate as a treatment option."

Answered by AI

What adverse effects have been reported regarding Ixazomib Citrate?

"Based on the available evidence, our team has assigned a score of 2 to Ixazomib Citrate's safety. This is because Phase 2 trials have provided some proof that this medication is safe but no data confirming its efficacy yet."

Answered by AI

Can you explain what medical issues Ixazomib Citrate is routinely utilized to treat?

"Ixazomib Citrate can be administered to patients suffering from multiple myeloma, relapsed and/or refractory lymphoma, and chronic lymphocytic leukemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Leona Holmberg 2015. "Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02619682.

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