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MRD Detection Methods for Multiple Myeloma

N/A

Recruiting

Led By Andrzej Jakubowiak, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Females of childbearing potential (FCBP) must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) if continued on lenalidomide as part of standard of care and 2) for at least 28 days after discontinuation of lenalidomide

ECOG performance status less than or equal to 2 (Karnofsky > 60%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will also compare the accuracy of liquid biopsies (blood tests) to standard bone marrow biopsies in detecting MRD.

Who is the study for?

This trial is for adults over 18 with multiple myeloma who've had initial treatment and at least a year of maintenance therapy without signs of active disease. They must be in good health, able to undergo bone marrow tests, and women must use contraception if necessary.Check my eligibility

What is being tested?

The study aims to see if patients with no measurable residual disease can stop their post-transplant maintenance therapy safely. It uses advanced imaging and lab tests including PET/CT scans, flow cytometry, NGS, and mass spectrometry.See study design

What are the potential side effects?

Since the intervention involves discontinuing maintenance medications rather than adding new ones, side effects may include potential return of myeloma symptoms or progression due to lack of ongoing treatment.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use two reliable birth control methods or abstain from sex if I can have children and am on lenalidomide.

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I can take care of myself but might not be able to do heavy physical work.

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My last PET/CT scan was within 1.5 years and showed no signs of myeloma.

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My last bone marrow test was within 2 years and showed no minimal residual disease.

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I am willing and able to have a bone marrow test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Determine the MRD conversion rate

Median Progression Free Survival rate

Median overall survival rate

Secondary outcome measures

Determine the difference in MRD detection by NGS

NGS-based Minimal Residual Disease testing determined by the ClonoSeq assay

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRD2STOP ARMExperimental Treatment2 Interventions

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,693 Total Patients Enrolled

16 Trials studying Multiple Myeloma

1,913 Patients Enrolled for Multiple Myeloma

Andrzej Jakubowiak, MDPrincipal InvestigatorUniversity of Chicago

2 Previous Clinical Trials

297 Total Patients Enrolled

2 Trials studying Multiple Myeloma

297 Patients Enrolled for Multiple Myeloma

Media Library

Screening Phase Clinical Trial Eligibility Overview. Trial Name: NCT04108624 — N/A

Multiple Myeloma Clinical Trial 2023: Screening Phase Highlights & Side Effects. Trial Name: NCT04108624 — N/A

Screening Phase 2023 Treatment Timeline for Medical Study. Trial Name: NCT04108624 — N/A

Multiple Myeloma Research Study Groups: MRD2STOP ARM

Frequently Asked Questions

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

Are there still openings for participants in this clinical research?

"Affirmative. According to the information on clinicaltrials.gov, this trial is currently recruiting patients who it first posted about in October of 2019 and updated most recently around January 8th 2021. 56 participants are needed from 1 study site."

Answered by AI

What is the maximum enrollment capacity for this clinical trial?

"Affirmative. Clinicaltrials.gov data states that this trial, which was launched on October 30th 2019, is actively enlisting people into the research project. The clinical study requires 56 participants from one medical facility to be recruited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess for Measurable Residual Disease (MRD) in Multiple Myeloma Patients

2019. "Study to Assess for Measurable Residual Disease (MRD) in Multiple Myeloma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04108624.