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Clinical Trial Details

Geo Regions

Category

Hematological Malignancies

Elranatamab

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
Phase 1
NCT06215118

Active enrolling

Globe
Locations

United States, Canada

Study design

Participant Group/Arm

EXPERIMENTAL: Part 1 Dose Escalation

Non-randomized elranatamab plus iberdomide

Intervention/Treatment

DRUG: Elranatamab

BCMA-CD3 bispecific antibody

DRUG: Iberdomide

cereblon-modulating agent
Participant Group/Arm

EXPERIMENTAL: Part 2 Dose Randomization

Randomized elranatamab plus iberdomide

Intervention/Treatment

DRUG: Elranatamab

BCMA-CD3 bispecific antibody

DRUG: Iberdomide

cereblon-modulating agent
Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
  • Prior diagnosis of multiple myeloma as defined by IMWG criteria
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL by SPEP
  • Urinary M-protein excretion ≥200 mg/24 hour by UPEP
  • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65)
  • Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  • Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  • ECOG performance status 0-1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Exclusion criteria
  • Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
  • Participants with any active, uncontrolled bacterial, fungal, or viral infection
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Previous treatment with:
  • BCMA-directed or CD3 redirecting therapy
  • Iberdomide (CC-220) or Mezigdomide
  • Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
  • Administration with an investigational product within 30 days preceding the first dose of study intervention
  • Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Key dates

Study start date
  • February 2024
Estimated primary completion date
  • July 2028

Key endpoints

Primary Outcome Measures
Outcome Measure

Part 1: Number of participants with dose limiting toxicity (DLT)

Measure Description

Dose limiting toxicity rate based on dose limiting toxicity evaluable participants

Time Frame

Cycle 1, about 28 days

Outcome Measure

Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment

Measure Description

Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.

Time Frame

Assessed from baseline up to 90 days after last dose of study treatment

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment

Measure Description

Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.

Time Frame

Assessed from baseline up to 90 days after last dose of study treatment

Outcome Measure

Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity

Measure Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship

Time Frame

Assessed from baseline up to 90 days after last dose of study treatment

Outcome Measure

Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities

Measure Description

Laboratory abnormalities as characterized by type, frequency, severity

Time Frame

Assessed from baseline up to 90 days after last dose of study treatment

Outcome Measure

Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)

Measure Description

Percent of participants having confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) per IMWG criteria as determined by investigator

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)

Measure Description

Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Time to Response (TTR)

Measure Description

For participants with an objective response per IMWG criteria, TTR is the time from first dose to the first documentation of objective response that is subsequently confirmed

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Duration of Response (DOR)

Measure Description

For participants with an objective response per IMWG criteria, DOR is the time from first documentation of objective response that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Duration of Complete Response (DOCR)

Measure Description

For participants with a Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria, DOCR is the time from the first documentation of CR/sCR that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Time of Progression Free Survival (PFS)

Measure Description

Progression free survival (IMWG criteria)

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Time of Overall Survival (OS)

Measure Description

The duration of time from first dose of study treatment to death

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate

Measure Description

The proportion of participants achieving CR+sCR with negative MRD per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death, or start of new anticancer therapy.

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Concentrations of elranatamab

Measure Description

Pre-dose and post-dose concentrations of elranatamab

Time Frame

Assessed for approximately 2 years

Outcome Measure

Part 1 and Part 2: Concentrations of iberdomide

Measure Description

Pre-dose concentrations of iberdomide

Time Frame

Assessed for approximately 4 months

Outcome Measure

Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab

Measure Description

Percent of participants with positive ADA to elranatamab when given in combination with iberdomide

Time Frame

Assessed for approximately 2 years

Secondary Outcome Measures table for Clinical Trial

Number of participants

100

Collaborators and investigators

Sponsor: Pfizer

Collaborator: Bristol-Myers Squibb

This information is current as of August 9th 2024.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06215118