The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will: 1. Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-. 2. Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status. 3. Increase the length of time that participants' disease responds to treatment. The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants will receive Linvoseltamab intravenously (IV) according to the following schedule and regimen, for up to 24 cycles, each cycle lasting 28 days: * Cycle 1 Day 1: 5mg * Cycle 1 Day 8: 25mg * Cycle 1 Days 15, 22: 100mg * Cycles 2 and 3, Days 1, 8, 15, 22: 100mg * Cycles 3 and 6, Days 1 and 15: 100mg * Cycles 7 through 24: 100mg
Participants will take 10mg of Lenalidomide maintenance therapy standard of care by mouth daily from days 1 through 21 of each 28 day cycle of Linvoseltamab therapy. Lenalidomide therapy will begin on Cycle 2 Day 1 of Linvoseltamab therapy.
University of Miami
Miami, Florida, United States
RECRUITINGMinimum Residual Disease Negative Conversion Rate
The number of patients who experience MRD negativity (10\^-5 sensitivity by 12 cycles of linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients. MRD negativity rate (\<10\^-5) by 12 cycles of linvoseltamab
Time frame: 12 months
Minimum Residual Disease Negative Conversion Rate
The number of patients who experience MRD negativity (10\^-5 sensitivity) by 6 months of Linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients.
Time frame: 6 months
Sustained MRD Negativity Rate
The sustained rate of MRD-negativity, at a sensitivity of \<10\^-5, among participants will be reported. The duration of time in months measured from the first time the participant achieves an MRD-negative bone marrow (BM) biopsy result until the time the participant has relapsed from MRD-negativity objectively documented with an MRD-positive BM result.
Time frame: Up to 2 years
Overall Response Rate
The number of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response or minimal response (MR) to study therapy. Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Time frame: Up to 12 months
Best Overall Response (BOR)
The best overall response is defined as the best response by the percentage of participants recorded from start of study therapy until the completion of 12 cycles of study therapy. Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Time frame: Up to 12 months
Duration of Response (DOR)
Duration of response is defined as the elapsed time in months from the time the criteria are met for achieving partial response (PR) or better until the time of progressive disease (PD) is objectively documented. Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Time frame: Up to 4.5 years
Progression-Free Survival (PFS)
PFS is defined as the elapsed time in months from the start of study therapy until first documented progressive disease (PD). Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Time frame: Up to 4.5 years
Overall Survival (OS)
Overall survival (OS) is defined as the elapsed time in months from start of study therapy to death or censoring at last known time point that participant was known to be alive (may be based on clinic visit or phone call, etc.)
Time frame: Up to 4.5 years
Number of Participants Experiencing Treatment-related Adverse Events
The number of participants experiencing all Grade and Grade ≥3 treatment-related adverse events will be recorded. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, per physician discretion.
Time frame: Up to 27 months
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