Clinical trial NCT05462639: Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Erlanatamab
Expanded Access
MM17
MagnetisMM-17
BCMA
BCMA antibody
Advanced multiple myeloma
Relapse/Refractory
RRMM
MagnetisMM
MagnetisMM US
Bispecific Antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-07-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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.

Detailed 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.

Eligibility criteria: 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)

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