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

Multiple Myeloma Clinical Trial

— MAGNETISMM17  

Official title:

ELRANATAMAB (PF-06863135) MONOTHERAPY EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT05462639
• Other study ID #: C1071017
• Status: Available

Study information

• Verified date: March 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: Expanded Access

Clinical Trial Summary

Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.

This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.

Description:

Study C1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma.

Each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior diagnosis of MM as defined according to IMWG criteria .

• Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.

• Measurable disease at screening based on IMWG criteria as defined by at least 1 of the following:

• Serum M-protein =0.5 g/dL (=5 g/L)

• Urinary M-protein excretion =200 mg/24 hours

• Involved FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).

• Refractory to at least one IMiD, one PI, and one anti-CD38 antibody.

• Relapsed/refractory to last anti-MM regimen.

• ECOG performance status 0-1.

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.

• Not pregnant, willing to use contraception

Exclusion Criteria:

• Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD

• Previous treatment with BCMA directed therapy;

• Active HBV, HCV, SARS- CoV-2, HIV or any active, uncontrolled bacterial, fungal, or viral infection.

Active infections must be resolved at least 14 days prior to enrollment.

• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.

• Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	McGill University Health Centre	Montréal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	Blood and Marrow Transplant Group of Georgia	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Georgia Cancer Center at Augusta University	Augusta	Georgia
United States	MSK Basking Ridge	Basking Ridge	New Jersey
United States	OhioHealth Arthur G.H. Bing, MD Cancer Center	Columbus	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	MSK Commack	Commack	New York
United States	Baylor Scott & White Charles A. Sammons Cancer Center	Dallas	Texas
United States	Baylor University Medical Center	Dallas	Texas
United States	Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy	Dallas	Texas
United States	Texas Oncology	Dallas	Texas
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	MSK Westchester	Harrison	New York
United States	Franciscan Health	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Memorial Sloan Kettering Cancer Center	Long Island City	New York
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)	Los Angeles	California
United States	Baptist Hospital of Miami	Miami	Florida
United States	Miami Cancer Institute	Miami	Florida
United States	MSK Monmouth	Middletown	New Jersey
United States	MSK Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	UC Irvine Health	Orange	California
United States	UC Irvine Medical Center	Orange	California
United States	Memorial Cancer Institute at Memorial Hospital West	Pembroke Pines	Florida
United States	Memorial Cancer Institute at Memorial Hospital West	Pembroke Pines	Florida
United States	Memorial Cancer Institute at Memorial Hospital West	Pembroke Pines	Florida
United States	Memorial Hospital West Laboratory Services	Pembroke Pines	Florida
United States	MSK Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

External Links

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