Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

Conditions

• Multiple Myeloma
• Myeloma
• Refractory Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elotuzumab — DRUG
  Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via intravenous (into the vein) infusion per protocol.
• Iberdomide — DRUG
  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.
• Dexamethasone — DRUG
  Synthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care.

Study Details

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)

Key Dates

Start date

Nov 1, 2024

Status verified

Nov 2025

Primary completion

Dec 31, 2029

Completion

Dec 31, 2034

Study Design

Enrollment

49 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicity (DLT) [Phase I] [ Time Frame: Up to 4 weeks ]

Central Contacts

• Omar Nadeem, MD
  617-632-4703
  [email protected]

Locations (3)

Find similar trials in Boston, MA

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