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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    56
  • sponsor
    University of Chicago
Updated on 4 March 2022
cancer
maintenance therapy
bone marrow procedure
serum proteins
lenalidomide
bortezomib
revlimid
electrophoresis
daratumumab
ixazomib
pomalidomide

Summary

This study is to assess for Measurable Residual Disease (MRD) in multiple myeloma at a deeper level than what is currently available by combining novel imaging and laboratory techniques, determine if patients who are MRD-negative by these multiple modalities can safely and effectively discontinue post-transplant maintenance therapy, and determine if liquid biopsies is a more accurate and/or less invasive sampling technique for multiple myeloma.

The purpose of this research is to determine if patients who are MRD-negative by multiple modalities ("multimodality MRD-negative") can safely and effectively discontinue post-transplant maintenance therapy (single agent lenalidomide, pomalidomide, bortezomib, or ixazomib) after receiving at least one year of maintenance therapy.

Details
Condition Multiple Myeloma
Treatment Screening Phase, Discontinuation Phase
Clinical Study IdentifierNCT04108624
SponsorUniversity of Chicago
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females > 18 years of age
ECOG performance status less than or equal to 2 (Karnofsky > 60%)
Patients with a diagnosis of multiple myeloma who have undergone initial treatment, with or without autologous stem cell transplant, and currently treated with single-agent maintenance therapy (lenalidomide, pomalidomide, bortezomib, daratumumab, or ixazomib) for a duration of at least 1 year. The 1 year duration can include time spent receiving at least 8 cycles of doublet or triplet induction regimens OR multi-agent post-transplant maintenance prior to conversion to single agent maintenance therapy
Patients must have had their most recent bone marrow testing within the last 2 years and negative for MRD by flow cytometry (with a sensitivity of at least 10-5) or by NGS with a sensitivity of at least 10-5
Patients must have achieved a CR (CR) by IMWG consensus response criteria. For patients with a persistent low level paraprotein ('M-spike'), mass spectrometry may be used to determine if the paraprotein is significant or not. Results of mass spectrometry may be used to supercede results of serum protein electrophoresis
Patients must have a most recent PET/CT within the last 1.5 years without evidence of myeloma disease
Must have baseline bone marrow sample that can be used for clonality identification for NGS and mass spectrometry if not already performed
Willing and able to undergo a bone marrow biopsy and aspiration
Ability to understand and the willingness to sign a written informed consent document
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
All participants in the US must have already been consented to and registered into the mandatory Revlimid REMS program and be willing and able to comply with the requirements of Revlimid REMS
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the intervention are eligible for this trial

Exclusion Criteria

Progressive disease as determined per IMWG consensus response criteria
Have not met the criteria for CR by IMWG consensus response criteria
MRD-positive disease by flow cytometry, NGS (1 in 1,000,000 cells), or PCR
Concomitant hematologic malignancy
Known or suspected amyloidosis
Unwilling to undergo a bone marrow biopsy
Unwilling to discontinue maintenance therapy
Any clinically significant medical disease or condition that, in the Treating Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
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