This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.
This is an open label phase II study that will enroll patients with relapsed and refractory multiple myeloma after four or more lines of therapy who received idecabtagene vicleucel as standard of care. The research involves study visits and receiving the study drug. Participants will receive the study drug, elranatamab, for up to 6 months and will be followed for as long as they remain in the study, until confirmed progressive disease (disease worsening), or until initiation of other myeloma treatment. Elranatamab is a type of antibody (a protein produced by the body's immune system when it detects harmful substances) that works by binding to both T-cells (part of the immune system) and myeloma cells. The drug then activates T-cells to kill the myeloma cells. In this study we are researching whether multiple myeloma progresses after elranatamab administration. The U.S. Food and Drug Administration (FDA) has not approved elranatamab as a treatment for any disease. It is expected that about 32 people will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
subcutaneous (under the skin) injection
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGBeth-Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGComplete Response (CR) rate or stringent CR (sCR) post consolidation therapy
Disease response will be assessed using the International Myeloma Working Group Response Criteria (IMWG)
Time frame: The time from start of treatment to first date that progressive disease is objectively documented or death due to any cause, for up to 5 years. Participants without events reported are censored at the last disease evaluation.
Progression-free survival
Progression-Free Survival (PFS) is defined as the time from or registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. This will be estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
Time frame: The time from registration to the earlier of progression or death due to any cause, for up to 5 years. Participants alive without disease progression are censored at date of last disease evaluation
Incidence of adverse events (AEs)
Adverse events will be evaluated using CTCAE version 5
Time frame: 3 years
Objective response rate (ORR)
ORR will be evaluated using the IMWG Uniform Response criteria
Time frame: From start of treatment to 2 years post-treatment
Overall survival (OS)
Overall Survival (OS) is defined as the time from or registration to death due to any cause, or censored at date last known alive. Estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
Time frame: From start of treatment to 2 years post-treatment
Minimum Residual Disease (MRD)-positive to MRD-negative conversion rate
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MRD-positive to MRD-negative conversion rate is the proportion of MRD-positive participants that become MRD-negative. Point estimates of MRD positivity and negativity rates will be calculated along with the 2-sided 95% CIs using the Clopper-Pearson method.
Time frame: 6 months
Rate of sustained MRD-negativity of ≥6 or ≥12 months
Sustained MRD negativity rate is the proportion of participants with MRD negativity sustained over at least 6 months or at least 12 months from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy. Point estimates of MRD negativity rate will be calculated along with the 2-sided 95% Confidence Interval (CIs) using the Clopper-Pearson method.
Time frame: 6 years
Time to MRD-negativity
MRD negativity rate is the proportion of participants with negative MRD per IMWG sequencing criteria from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy. Point estimates of MRD negativity rate will be calculated along with the 2-sided 95% CIs using the Clopper-Pearson method.
Time frame: From start of treatment to 2 years post-treatment
Duration of response (DOR)
The following description information was pulled from NIH: Duration of response is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response. This is estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
Time frame: From start of treatment to 2 years post-treatment