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

Korábbi kezelés

• Concomitant hematologic malignancy.
• Unwilling to discontinue maintenance therapy.

Más betegség

• Progressive disease as determined per IMWG consensus response criteria.
• MRD-positive disease by flow cytometry, NGS (1 in 1,000,000 cells), or PCR.
• 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.

Egyéb

• Have not met the criteria for CR by IMWG consensus response criteria.
• Known or suspected amyloidosis.
• Unwilling to undergo a bone marrow biopsy.

• 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.