A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.

Pfizer

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

MagnetisMM-8

PF-06863135

BCMA-CD3 Bispecific

Multiple Myeloma

Bispecific

Elranatamab

Refractory Multiple Myeloma

Bispecific Antibody

Relapsed Multiple Myeloma

Myeloma

BCMA

Treatments

Drug: Elranatamab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05228470

C1071008

Details and patient eligibility

About

The purpose of this study is to understand the study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells to go out. Sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma.

Elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. We are seeking Chinese participants to take part in this study. The study will be 2 parts, called part 1b and part 2. In part 1b, participants will receive Elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. We will monitor participants' safety and reactions to the study medicine. This will help us understand the dosage of Elranatamab to be used safely.

In part 2 of the study, participants will receive Elranatamab and their multiple myeloma growth will be monitored. This will help us understand if Elranatamab, when used alone, may be a therapy for refractory multiple myeloma. Participants in this part of the study are expected to take part for about 2 years.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
Measurable disease, as defined by at least 1 of the following:
Serum M-protein ≥0.5 g/dL
Urinary M-protein excretion ≥200 mg/24 hours
Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
Refractory to at least one IMiD
Refractory to at least one PI
Refractory to at least one anti-CD38 antibody
Relapsed/refractory to last anti-myeloma regimen
ECOG performance status ≤2
Adequate BM function characterized by the following:
1. Absolute neutrophil count ≥1.0 × 10^9/L
2. Platelets ≥ 25 × 10^9/L
3. Hemoglobin ≥8 g/dL
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Not pregnant and willing to use contraception

Exclusion criteria

Smoldering multiple myeloma
Active Plasma cell leukemia
Amyloidosis
POEMS syndrome
Stem cell transplant or active GVHD within 12 weeks prior to enrollment.
Previous treatment with an anti-BCMA directed therapy
Impaired cardiovascular function or clinically significant cardiovascular diseases
Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)