The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Hematological Malignancies

Elranatamab

A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY (TRIPLE-CLASS REFRACTORY MM)
Phase 2
NCT05228470

Active Not-enrolling

Globe
Locations

China

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Study design

Participant Group/Arm

EXPERIMENTAL: Elranatamab

BCMA-CD3 bispecific antibody

Intervention/Treatment

DRUG: Elranatamab

BCMA-CD3 bispecific antibody

Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
  • Measurable disease, as defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL
  • Urinary M-protein excretion ≥200 mg/24 hours
  • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  • Refractory to at least one IMiD
  • Refractory to at least one PI
  • Refractory to at least one anti-CD38 antibody
  • Relapsed/refractory to last anti-myeloma regimen
  • ECOG performance status ≤2
  • Adequate BM function characterized by the following:
    1. Absolute neutrophil count ≥1.0 × 10\^9/L 
    2. Platelets ≥ 25 × 10\^9/L 3. Hemoglobin ≥8 g/dL
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 

  • Not pregnant and willing to use contraception

     

Exclusion criteria
  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • Amyloidosis
  • POEMS syndrome
  • Stem cell transplant or active GVHD within 12 weeks prior to enrollment.
  • Previous treatment with an anti-BCMA directed therapy
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
  • Active HBV, HCV, SARS-CoV2, HIV, or 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 administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Key dates

Study start date
  • December 2021
Estimated primary completion date
  • February 2025

Key endpoints

Primary Outcome Measures
Outcome Measure

Phase 1b: Number of participants with dose-limiting toxicities (DLT)

Measure Description

Number of participants with DLTs

Time Frame

Up to 4 weeks

Outcome Measure

Phase 2: Objective response rate

Measure Description

Objective response rate (IMWG response criteria)

Time Frame

Up to approximately 2 years

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

Duration of response

Measure Description

Duration of response (IMWG response criteria)

Time Frame

Up to approximately 2 years

Outcome Measure

Cumulative complete response rate

Measure Description

Cumulative complete response rate (IMWG response criteria)

Time Frame

Up to approximately 2 years

Outcome Measure

Duration of cumulative complete response

Measure Description

Duration of cumulative complete response (IMWG response criteria)

Time Frame

Up to approximately 2 years

Outcome Measure

Progression free survival

Measure Description

Progression free survival (IMWG response criteria)

Time Frame

Up to approximately 2 years

Outcome Measure

Overall survival (OS)

Measure Description

Time Frame

Up to approximately 2 years

Outcome Measure

Time to response (TTR)

Measure Description

Time to response (IMWG response criteria)

Time Frame

Up to approximately 2 years

Outcome Measure

Minimal residual disease negativity rate

Measure Description

Minimal residual disease negativity rate (IMWG response criteria)

Time Frame

Up to approximately 2 years

Outcome Measure

Frequency of treatment-emergent adverse events

Measure Description

Type and severity (including severity per NCI CTCAE v5)

Time Frame

Up to approximately 2 years

Outcome Measure

Frequency of laboratory abnormalities

Measure Description

Complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)

Time Frame

Up to approximately 2 years

Outcome Measure

Serum Concentration of Elranatamab (PF-06863135)

Measure Description

Serum concentrations of Elranatamab (PF-06863135) will be reported.

Time Frame

Up to approximately 2 years

Outcome Measure

Immunogenicity of elranatamab (PF-06863135)

Measure Description

Immunogenicity of elranatamab (anti-drug antibodies against elranatamab)

Time Frame

Up to approximately 2 years

Outcome Measure

Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)

Measure Description

The QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.

Time Frame

Up to approximately 2 years

Outcome Measure

Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire myeloma-specific module (EORTC QLQ-MY20)

Measure Description

The EORTC MY20 is a myeloma-specific module to assess quality of life in patients with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items)

Time Frame

Up to approximately 2 years

Outcome Measure

Change from Baseline in Patient-Reported Outcomes as Assessed by EuroQol Five Dimension Questionnaire (EQ-5D)

Measure Description

The EQ-5D is a 6-item patient-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components, a Health State Profile which has individuals rate their level of problems in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a VAS in which patients rate their overall health status from 0 (worst imaginable) to 100 (best imaginable).

Time Frame

Up to approximately 2 years

Outcome Measure

Change from Baseline in Patient-Reported Outcomes as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ CIPN20)

Measure Description

The EORTC QLQ CIPN20 is a module developed to assess chemotherapy-induced peripheral neuropathy. It contains 20 items which can be grouped into a sensory subscale (9 items), motor subscale (8 items) and autonomic subscale (3 items).

Time Frame

Up to approximately 2 years

Secondary Outcome Measures table for Clinical Trial

Number of participants

39

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of April 16th 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. NCT05228470