A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

Multiple Myeloma Clinical Trial

— MagnetisMM-9  

Official title:

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05014412
• Other study ID #: C1071009
• Secondary ID: MagnetisMM-9
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 7, 2021
• Est. completion date: May 17, 2025

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

Description:

The purpose of the study (Part 1 and Part 2) of the study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in participants with relapsed/refractory multiple myeloma. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those participants. Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: May 17, 2025
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
• Measurable disease, as defined by at least 1 of the following:

1. Serum M-protein >0.5 g/dL by SPEP

2. Urinary M-protein excretion >200 mg/24 hours by UPEP

3. 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 =1
• 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
• POEMS syndrome
• Amyloidosis
• Waldenström's macroglobulinemia
• Known active CNS involvement or clinical signs of myelomatous meningeal involvement
• Stem cell transplant within 12 weeks prior to enrollment or active GVHD
• 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
• Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
• Live attenuated vaccine within 4 weeks of the first dose
• 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)
• Known or suspected hypersensitivity to the study intervention, or any of its excipients

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
BCMA-CD3 bispecific antibody

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kobe City Medical Center General Hospital	Kobe-city	Hyogo
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust NIHR	London
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey
United States	University of Michigan	Ann Arbor	Michigan
United States	St. David's South Austin Medical Center	Austin	Texas
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Institute	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Cancer Care & Hematology - Fort Collins	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	UF Health Shands Cancer Hospital	Gainesville	Florida
United States	UF Health Shands Hospital	Gainesville	Florida
United States	UCHealth Cancer Care & Hematology - Greeley	Greeley	Colorado
United States	UCHealth Cancer Care & Hematology - Loveland	Loveland	Colorado
United States	MSK Bergen	Montvale	New Jersey
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Tulane Cancer Center Office of Clinical Research	New Orleans	Louisiana
United States	Tulane Medical Center	New Orleans	Louisiana
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	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Pikeville Medical Center, INC	Pikeville	Kentucky
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
United States	Blood Cancer and Stem Cell Transplant Clinic	San Antonio	Texas
United States	Methodist Healthcare System of San Antonio dba Methodist Hospital	San Antonio	Texas
United States	Methodist Hospital Investigational Pharmacy	San Antonio	Texas
United States	Methodist Plaza Clinical Trials Office	San Antonio	Texas
United States	Mayo Clinic	Scottsdale	Arizona
United States	MSK Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Japan,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 1 and 2)	Cytokine release syndrome severity assessed by American Society for Transplantation and Cellular Therapy (ASTCT) criteria	Cycle 1 (28 days)
Secondary	Incidence of Dose Limiting Toxicities (Part 2A and 2C)		28 days starting on the first dose of 116 or 152 mg
Secondary	Frequency of Adverse Events	Adverse Events as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, timing, seriousness, and relationship to elranatamab	Up to 90 days after last dose and for approximately 2 years
Secondary	Frequency of laboratory abnormalities		Assessed at every cycles [each cycle approximately 28 days]
Secondary	Objective response rate	Objective response rate per International Myeloma Working Group (IMWG) response criteria	Assessed approximately every 28 days and for approximately 2 years
Secondary	Complete Response Rate	Complete Response Rate per IMWG response criteria	Assessed approximately every 28 days and for approximately 2 years
Secondary	Time to response	Time to response per IMWG response criteria	Assessed approximately every 28 days and for approximately 2 years
Secondary	Duration of response	Duration of response per IMWG response criteria	Assessed approximately every 28 days and for approximately 2 years
Secondary	Duration of complete response rate	Duration of complete response rate per IMWG response criteria	Assessed approximately every 28 days and for approximately 2 years
Secondary	Progression Free Survival		Assessed approximately every 28 days for approximately 2 years
Secondary	Overall Survival		Approximately 2 years
Secondary	Minimal Residual Disease negativity rate	Minimal Residual Disease negativity rate assessed by central lab per IMWG sequencing criteria	Assessed approximately every 12 months and for approximately 2 years
Secondary	Pre- and postdose concentrations of elranatamab	Pharmacokinetic of elranatamab	Assessed approximately every 1 to 4 cycles [cycle of approximately 28 days]
Secondary	Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab	Immunogenicity of elranatamab	Assessed approximately every 1 to 6 cycles [cycle of approximately 28 days]

External Links

•   To obtain contact information for a study center near you, click here.
•   www.MultipleMyelomaMM9Study.com