A Phase I/II Study of Elotuzumab and Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Previously diagnosed with MM based on standard IMWG criteria

• Patient has given voluntary written informed consent before any study-related procedures not part of normal medical care are performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

• Patient who has been treated with at least 4 prior lines of anti-myeloma treatment including immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

• In addition, to at least 4 prior lines of anti-myeloma treatment, patient has received ide-cel in accordance with the FDA approved US Prescribing Information and has achieved at least a partial response, and is within 90 days of infusion

• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

• Screening Laboratory evaluations within the following parameters

‣ Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used more recently than 7 days prior to initiation of therapy)

⁃ Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions during the 7 days prior to initiation of therapy)

⁃ Hemoglobin ≥ 8.0 g/dL (RBC transfusions are permitted)

⁃ Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)

⁃ AST or ALT ≤ 3x ULN

⁃ Creatinine clearance ≥ 30 ml/min according to the Cockroft-Gault formula:

• Female CrCl = \[(140 - age in years) x weight in kg x 0.85\] / \[72 x serum creatinine in mg/dL\]

∙ Male CrCl = \[(140 - age in years) x weight in kg x 1.00\] / \[72 x serum creatinine in mg/dL\]

• Age ≥18 years.

• Ability to understand and the willingness to sign a written informed consent document.

• A Female of childbearing potential (FCBP) must:

‣ Have two negative pregnancy tests before enrollment and randomization into the clinical studies and prior to each re-supply of study drug during the clinical studies based on the frequency outlined in the Pregnancy Prevention Plan (PPP, Appendix D).

⁃ Sexually active FCBP must agree to use protocol-specified contraceptive methods during participation in the clinical studies and for at least 28 days after the last dose of study drug.

• Sexually active males (including those who have had a vasectomy) must agree to use protocol specified contraceptive methods during participation in the clinical studies and for at least 28 days after the last dose of study drug.

• All participants (male and female with or without childbearing potential) must agree to abstain from donating blood products for at least 28 days after the last dose of study drug and semen or sperm while taking study drug and for at least 28 days after the last dose of study drug.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Omar Nadeem, MD
Omar_Nadeem@dfci.harvard.edu
617-632-4703
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 49
Treatments
Experimental: Phase 1: Dose Escalation
Participants will be enrolled in a standard 3+3 dose escalation design to find the Maximum Tolerated Dose (MTD) of Iberdomide, starting at Dose Level 0 and increasing to Dose Level 1~* Baseline visit~* Cycle 1 through Cycle 2:~ * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily~ * Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily~ * Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Elotuzumab 1x daily~* Cycle 3 through End of Treatment:~ * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily~ * Day 1 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily~ * Day 1 of 28 Day Cycle: Predetermined dose of Elotuzumab 1x daily~* End of Treatment visit~* 14 Day Follow Up Visit: to be in-clinic after end of treatment visit~* Follow Up: Every 28 days for up to 2 years~* Dose expansion will proceed according to dose-limiting toxicity (DLT) guidelines per the protocol
Experimental: Phase 2: Dose Expansion
Participants will be enrolled and will complete study procedures as follows:~* Baseline visit~* Cycle 1 through Cycle 2:~ * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily.~ * Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily.~ * Days 1, 8, 15, and 22 of 23 Day Cycle: Predetermined dose of Elotuzumab 1x daily.~* Cycle 3 through End of Treatment:~ * Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily.~ * Day 1 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily.~ * Days 1, 8, 15, and 22 of 23 Day Cycle: Predetermined dose of Elotuzumab 1x daily.~* End of Treatment visit~* 14 Day Follow Up Visit: to be in-clinic after end of treatment visit.~* Follow Up: Every 28 days for up to 2 years
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, Celgene
Leads: Omar Nadeem, MD

This content was sourced from clinicaltrials.gov