The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. The names of the study drugs involved in this study are: * Iberdomide (a type of cereblon E3 ligase modulator) * Elotuzumab (a type of monoclonal antibody) * Dexamethasone (a type of steroid)
This is a phase I/II, open-label, non-randomized, single-stage study to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. Iberdomide has demonstrated some antitumor activity in laboratory studies. The U.S. Food and Drug Administration (FDA) has approved Elotuzumab as a treatment option for Multiple Myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias. The U.S. Food and Drug Administration (FDA) has not approved Iberdomide as a treatment for Multiple Myeloma. The research study procedures include screening for eligibility, study treatment visits, bone marrow biopsies, blood and urine tests, electrocardiograms (ECGs), X-rays, and Positron Emission Tomography (PET) scans, Computerized Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. It is expected about 49 people will take part in this research study. Bristol-Myers Squibb and Celgene, a BMS company, are supporting this research study by providing study drug and providing funding for the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via intravenous (into the vein) infusion per protocol.
A cereblon E3 ligase modulator, 0.15mg, 0.2mg, 0.3mg, 0.45mg, 0.6, and 0.75 mg strength capsule taken orally per protocol.
Synthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care.
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGNumber of Participants Experiencing Dose Limiting Toxicity (DLT) [Phase I]
Toxicities are to be assess according to the CTCAE v5. DLT criteria could be referred as follow: * Grade ≥3 non-hematologic toxicity that cannot be clearly related to disease progression or other circumstances clearly not linked to study treatment. * Grade 4 thrombocytopenia (platelet count \< 25,000 cells/ mm3) on more than one occasion that cannot be attributed to underlying disease * Grade 3 thrombocytopenia with bleeding * Grade 4 neutropenia (ANC \< 500 cells/mm3) lasting for \>7 days * Any Grade 5 event, unless due to progressive disease
Time frame: Up to 4 weeks
Maximum Tolerated Dose (MTD) [Phase I]
The MTD is defined as the highest dose level where at most 1 participant (of the 6 treated) develops a DLT, and 2 or more of the 3 to 6 participants developed a DLT at the next higher dose level unless the MTD is identified as dose level 1.
Time frame: Up to 4 weeks
Progression-free Survival Rate at 12 months (rPFS12)
rPFS12 is defined as the proportion fo participants who are alive and progression-free at 12 months after treatment initiation. Participants who have died, progressed, or lost to follow-up prior to the primary assessment visit 12 months after treatment initiation will be counted in the denominator for the primary endpoint.
Time frame: Up to 12 months
Minimal Residual Disease (MRD) Rate
MRD rate is defined as the proportion of participants who still have detectable cancer cells after treatment. IMWG MRD negativity category is listed in protocol section 11.
Time frame: Up to 12 months
Median Time-to-progression (TTP)
Median TTP is defined as the time from start of ide-cel treatment to progression or censored at date of last disease evaluation for those without progression reported based on Kaplan-Meier method.
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Time frame: Up to 4 years
Duration of Response (DOR)
DOR based on Kaplan-Meier methodology is defined as the time from initiation of first response to ide-cel until first documentation of disease progression or death. Participants who have not progressed are censored at the date last known progression-free.
Time frame: Up to 4 years
Duration of Complete Response (DOCR)
DOCR based on Kaplan-Meier methodology is defined as the time from initiation of CR after ide-cel therapy to first documentation of disease progression or death. Participants who have not progressed are censored at the date last known progression-free.
Time frame: Up to 4 years
Median Overall Survival (OS)
Median OS based on Kaplan-Meier methodology is defined as the time from start of ide-cel treatment to death due to any cause or censored at date last known alive.
Time frame: Up to 4 years
Extramedullary disease (EMD) response rate
EMD is defined as the percentage of participants with baseline EMD who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during treatment.
Time frame: Up to 12 months
Grade 3-5 Treatment-Related Toxicity Rate
The percentage of participants who experienced a maximum grade 3-5 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Time frame: Up to 4 years