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Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

ConditionsMyelomaMultiple MyelomaRefractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOmar Nadeem, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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any study-related procedures not part of normal medical care are performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

Disqualifiers

Prior exposure to Iberdomide

Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.

Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy

Known central nervous system involvement.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

49 Participants
are divided into 2 treatment groups
Group A: Phase 1: Dose EscalationExperimental treatment 3 interventions
Group B: Phase 1: Dose ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Dose Limiting Toxicity (DLT)

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
2

Maximum Tolerated Dose (MTD)

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

Secondary outcomes

1

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
2

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.

Time frame
Up to 4 years
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Omar Nadeem, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Celgene

Collaborator

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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