Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM
NCT Number: NCT06518551
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Myeloma|Multiple Myeloma|Refractory Multiple Myeloma
Interventions: DRUG: Elotuzumab|DRUG: Iberdomide|DRUG: Dexamethasone
Sponsor: Omar Nadeem, MD
Collaborators: Bristol-Myers Squibb|Celgene
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 49
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2034-12-31
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
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)

Primary Outcome Measures: Number 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, 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., 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., Up to 12 months
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., Up to 4 years