Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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.
