RecruitingPhase 4NCT06057402

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

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


Sponsor

Pfizer

Enrollment

80 participants

Start Date

Oct 3, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

Interventions

DRUGElranatamab

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


Locations(25)

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, United States

UCHealth Harmony

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Longs Peak Hospital

Longmont, Colorado, United States

UCHealth Longs Peak Medical Center

Longmont, Colorado, United States

UCHealth - Medical Center of the Rockies

Loveland, Colorado, United States

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, United States

University of Miami Hospital and Clinics Deerfield Beach

Deerfield Beach, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

University of Miami Hospital and Clinics - Griffin Cancer Research Building

Miami, Florida, United States

University of Miami Hospital and Clinics

Miami, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Peking University Third Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Shandong Provincial Hospital

Jinan, Shandong, China

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06057402


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