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

Multiple Myeloma Clinical Trial

— MagnetisMM15  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057402
• Other study ID #: C1071015
• Secondary ID: 2023-505200-33-0
• Status: Recruiting
• Phase: Phase 4
• Start date: October 3, 2023
• Est. completion date: February 22, 2031

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 22, 2031
• Est. primary completion date: February 22, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Australia	Epworth Freemasons	Melbourne	Victoria
Australia	Epworth Hospital	Richmond	Victoria
Australia	Slade Pharmacy	Richmond	Victoria
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	McGill University Health Centre	Montréal	Quebec
France	Hôpital Saint-Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite	Rhône
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
United States	Franciscan Health	Indianapolis	Indiana
United States	UC Irvine Health	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nonserious adverse events (AEs) leading to permanent discontinuation		A minimum of 90 days after the last dose of study drug
Primary	Incidence of serious adverse events (SAEs)		A minimum of 90 days after the last dose of study drug

External Links

•   To obtain contact information for a study center near you, click here.