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MRD Detection Methods for Multiple Myeloma

N/A
Waitlist Available
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%)
Must not have
Known or suspected amyloidosis.
Unwilling to discontinue maintenance therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with or suspected to have amyloidosis.
Select...
I am not willing to stop my ongoing maintenance therapy.
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I have a blood cancer along with my current condition.
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I am not willing to have a bone marrow biopsy.
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My cancer is detectable at a very low level in my body.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the MRD conversion rate
Median Progression Free Survival rate
Median overall survival rate
Secondary study objectives
Determine the difference in MRD detection by NGS
NGS-based Minimal Residual Disease testing determined by the ClonoSeq assay

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MRD2STOP ARMExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
759,018 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,414 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
~6 spots leftby Jul 2025
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