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

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Updated on 4 March 2022

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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 Identifier	NCT04108624
Sponsor	University of Chicago
Last Modified on	4 March 2022

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