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Recruiting NCT06057402

Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

Phase IV Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Elranatamab.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, China, Japan +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES

Overview

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

Detailed description

This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Interventions

  • Drug Elranatamab
    Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Primary outcome measures

  • Incidence of nonserious adverse events (AEs) leading to permanent discontinuation [Time frame: A minimum of 90 days after the last dose of study drug]
  • Incidence of serious adverse events (SAEs) [Time frame: A minimum of 90 days after the last dose of study drug]

Eligibility criteria

Inclusion criteria

  • Participants must agree to follow the reproductive criteria as outlined in the protocol
  • Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).

Exclusion criteria

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 17 centers
  • UCI Health - Irvine Infusion Pharmacy ACC — Irvine
  • UC Irvine Health — Orange
  • UCI Health — Orange
  • UCHealth Poudre Valley Hospital — Fort Collins
  • UCHealth Harmony — Fort Collins
  • UCHealth Greeley Hospital — Greeley
  • Longs Peak Hospital — Longmont
  • UCHealth Longs Peak Medical Center — Longmont
  • … and 9 more centers
China · 4 centers
  • Peking University Third Hospital — Beijing
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Shandong Provincial Hospital — Jinan
  • The first Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Australia · 3 centers
  • Epworth Freemasons — Melbourne
  • Epworth Hospital — Richmond
  • Slade Pharmacy — Richmond
Canada · 3 centers
  • Arthur J.E. Child Comprehensive Cancer Centre — Calgary
  • Cross Cancer Institute — Edmonton
  • McGill University Health Centre — Montreal
Japan · 2 centers
  • Japanese Red Cross Medical Center — Shibuya-ku
  • University Hospital,Kyoto Prefectural University of Medicine — Kyoto
Spain · 2 centers
  • Clinica Universidad de Navarra — Pamplona
  • Hospital Universitario Doctor Peset — Valencia
Taiwan · 2 centers
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei

Identifiers

NCT: NCT06057402 · C1071015 · 2023-505200-33-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗