Home
Clinical Trials
Study of Elranatamab for Rela...

Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.

Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.

Safety refers to the measurement of:

i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).

ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infections

The study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

NCT05014412

Multiple Myeloma

ACTIVE_NOT_RECRUITING PHASE2

Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma

NCT05462639

Multiple Myeloma

NO_LONGER_AVAILABLE

A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

NCT05927571

Relapsed or Refractory Multiple Myeloma

RECRUITING PHASE1

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

NCT05675449

Multiple Myeloma

RECRUITING PHASE1

Study of Lacutamab in Peripheral T-cell Lymphoma

NCT04984837

Peripheral T Cell Lymphoma Relapse/Recurrence

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Treatment with elranatamab will be initiated using a 2-step-up priming regimen: the initial doses of elranatamab will be 12 mg (Cycle 1 Day 1) and 32 mg (Cycle1 Day 4). Participants should be hospitalized and monitored for toxicity (especially CRS/ICANS) for at least 2 days (\~48 hours) beginning on Cycle 1 Day 1, and for 1 day (\~24 hours) for Cycle1 Day 4. The dose of elranatamab should be increased to 76 mg on Cycle 1 Day 8 as long as the participant meets the redosing criteria or deferred until the criteria are met.

The scheme of administration includes weekly administrations for at least six 4-weeks cycles and, if patients have achieved at least PR (or better) persisting for at least 2 months, the dose interval should be changed from weekly to every other week. Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease and maintained for 12 months will stop therapy. After stopping therapy, and if the patient is in sustained undetectable measurable residual disease for at least 12 months, it would be possible to re-start treatment with elranatamab in case the measurable residual disease will be detectable or relapse from CR will occur. Patients who will not achieve undetectable measurable residual disease sustained for 12 months will receive continuous treatment until progressive disease. In both situations, the occurrence of unacceptable toxicity might result into the treatment discontinuation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma in Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

Intervention Model

SINGLE_GROUP

This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (Open Label)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elranatamab

Elranatamab will be administered by subcutaneous (SC) injection

Group Type EXPERIMENTAL

Elranatamab (PF-06863135)

Intervention Type DRUG

The scheme of administration includes weekly administrations for at least six 4-weeks cycles and, if patients have achieved at least PR (or better) persisting for at least 2 months, the dose interval should be changed from weekly to every other week. Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease (MRD) and maintained for 12 months will stop therapy. After stopping therapy, and if the patient is in sustained undetectable MRD for at least 12 months, it would be possible to re-start treatment with elranatamab in case the MRD will be detectable or relapse from CR will occur. Patients who will not achieve undetectable MRD sustained for 12 months will receive continuous treatment until progressive disease.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elranatamab (PF-06863135)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, 18 years or older (at the time consent is obtained).
* Patient who, in the investigator's opinion, is able to comply with the protocol requirements.
* Prior diagnosis of MM as defined according to IMWG criteria.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Relapse multiple myeloma patients that have received at least 1 or 2 prior lines of therapy including at least to one proteasome inhibitor (bortezomib, carfilzomib or ixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can be also have been exposed to pomalidomide) and at least one anti-CD38 monoclonal antibody (daratumumab or isatuximab).
* Patients must be refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.
* Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients in whom disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio.

Exclusion Criteria

* Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome (defined by the presence of peripheral neuropathy, organomegaly, endocrinopathy, monoclonal plasma-cells proliferative disorder, and skin changes) or plasma cell leukemia.
* Prior anti-BCMA treatment.
* Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.
* History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
* Stem cell transplant within 12 weeks prior to enrolment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

María-Victoria Mateos, MD

Role: STUDY_CHAIR

University of Salamanca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.