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Ixazomib Citrate for Multiple Myeloma

Phase 2

Waitlist Available

Led By Prashant Kapoor

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs for patients with multiple myeloma who have relapsed or who haven't responded to other treatments. The drugs will be given before a stem cell transplant, and researchers will see if the transplant, along with the new combination of drugs, is more effective than other treatments.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry

Secondary outcome measures

Number of Patients Experiencing Adverse Events Graded According to the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 12.1

Overall Response Rate

Percent of Patients Alive at 30 Months

+1 more

Other outcome measures

Change in Minimal Residual Disease (MRD) in Bone Marrow Assessed by Flow Cytometry

Engraftment Kinetics (White Blood Cells [WBC] and Platelet) Following Single Salvage Autologous Stem Cell Transplantation (ASCT)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib, pomalidomide, dexamethasone, ASCT)Experimental Treatment5 Interventions

INDUCTION (COURSES 1-4): Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days (courses 1-3) and 56 days (course 4) for up to 4 courses in the absence of disease progression or unacceptable toxicity. TRANSPLANTATION (COURSE 5): Between 2-4 weeks following Induction, patients undergo ASCT. CONSOLIDATION (COURSES 6-9): Beginning 60-120 days following ASCT, patients receive ixazomib citrate, pomalidomide, and dexamethasone as in Induction. Treatment repeats every 28 days (courses 6-8) and 56 days (course 9) for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE (COURSES 10+): Beginning 0-4 weeks following Consolidation, patients receive ixazomib citrate as in Induction. Courses repeat every 28 days 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

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~1730

Dexamethasone

2007

Completed Phase 4

~2590

Pomalidomide

2011

Completed Phase 2

~1020

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Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,208 Previous Clinical Trials

3,767,042 Total Patients Enrolled

76 Trials studying Multiple Myeloma

9,703 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,873 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,123 Patients Enrolled for Multiple Myeloma

Prashant KapoorPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

99 Total Patients Enrolled

2 Trials studying Multiple Myeloma

99 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.

How many patients are included in this trial?

"This particular trial is no longer looking for new participants. The listing was first posted on July 24th, 2017 and edited for the last time on July 14th, 2022. There are 827 other trials related to refractory plasma cell myeloma and 619 studies concerning Autologous Hematopoietic stem cell transplantation that are actively seeking patients."

Answered by AI

When is Autologous Hematopoietic Stem Cell Transplantation the best course of treatment?

"Autologous Hematopoietic Stem Cell Transplantation is the most common treatment for ophthalmia, sympathetic. This course of care can also help patients suffering from other eye conditions such as branch retinal vein occlusion and macular edema."

Answered by AI

Has the FDA cleared Autologous Hematopoietic Stem Cell Transplantation for use?

"Because Autologous Hematopoietic Stem Cell Transplantation is only in Phase 2, there is not yet any data supporting its efficacy. However, it did receive a 2 for safety because there is some evidence that the intervention is safe."

Answered by AI

Why did researchers start this clinical trial?

"The primary outcome of this trial is progression-free survival at 18 months (PFS18). Secondary outcomes include the incidence of adverse events, overall response rate, and partial response rate."

Answered by AI

Are we currently enrolling people in this clinical trial?

"This trial is no longer recruiting patients. The study was initially posted on July 24th, 2017 and last updated on July 14th, 2022. However, there are 827 other trials actively enrolling patients with refractory plasma cell myeloma and 619 Autologous Hematopoietic Stem Cell Transplantation trials that participants can explore."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma

2017. "Ixazomib Citrate, Pomalidomide, Dexamethasone, Stem Cell Transplant in Treating Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03202628.