MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Multiple Myeloma Clinical Trial

Official title:

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152575
• Other study ID #: C1071032
• Secondary ID: 2023-507871-23-0
• Status: Recruiting
• Phase: Phase 3
• Start date: February 8, 2024
• Est. completion date: March 24, 2028

Study information

• Verified date: June 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: Interventional

Clinical Trial Summary

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: - Are 18 years of age or older and have MM. - Have received treatments before for MM. - Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: - a shot under the skin at the study clinic - through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 492
• Est. completion date: March 24, 2028
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
• Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
• Measurable disease defined as at least 1 of the following: (a) Serum M-protein =0.5 g/dL; (b) Urinary M-protein excretion =200 mg/24 hours; (c) Serum involved immunoglobulin FLC =10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
• Have clinical laboratory values within the specified range.
• ECOG (Eastern Cooperative Oncology Group) performance status =2.
• Not pregnant or breastfeeding and willing to use contraception.

Exclusion Criteria:

• Smoldering multiple myeloma.
• Plasma cell leukemia.
• Amyloidosis.
• Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
• Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
• Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
• Any active, uncontrolled bacterial, fungal, or viral infection.
• Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
• Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
• Unable to receive investigator's choice therapy.
• Live attenuated vaccine within 4 weeks of the first dose of study intervention.
• Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
Elranatamab will be administered subcutaneously
• Elotuzumab
Elotuzumab will be administered intravenously
• Pomalidomide
Pomalidomide will be administered orally
• Dexamethasone
Dexamethasone will be administered orally
• Bortezomib
Bortezomib will be administered subcutaneously or intravenously
• Carfilzomib
Carfilzomib will be administered intravenously

Locations

Country	Name	City	State
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut
Brazil	Centro de Pesquisa Clínica - Área Administrativa	Porto Alegre	RIO Grande DO SUL
Brazil	Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Mae de Deus	Porto Alegre	RIO Grande DO SUL
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Jewish General Hospital	Montreal	Quebec
Czechia	Fakultni nemocnice Kralovske Vinohrady	Prague	Praha 10
Finland	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)	Helsinki	Uusimaa
Finland	Oulun yliopistollinen sairaala	Oulu	Pohjois-pohjanmaa
France	Hôpital NOVO	Cergy Pontoise	Val-d'oise
France	CHD Vendee	La Roche-sur-Yon	Vendée
France	Hôpital NOVO	Pontoise	Val-d'oise
France	Centre Hospitalier de Cornouaille	Quimper
France	Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau	Tours
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	St. Barbara-Klinik Hamm-Heessen	Hamm
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Koto	Tokyo
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	Shizuoka Cancer Center	Nagaizumi-cho,Sunto-gun	Shizuoka
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	Okayama Rosai Hospital	Okayama
Japan	National Hospital Organization Shibukawa Medical Center	Shibukawa	Gunma
Japan	Iwate Medical University Hospital	Shiwa-gun Yahaba-cho	Iwate
Japan	Toyohashi Municipal Hospital	Toyohashi	Aichi
Japan	Yamagata University Hospital	Yamagata
Norway	Sykehuset i Vestfold	Tønsberg	Vestfold
Norway	St. Olavs Hospital	Trondheim	Sør-trøndelag
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [cataluña]
Spain	Institut Català d'Oncologia (ICO) - Girona	Girona	Girona [gerona]
Spain	Centro de Diagnóstico y Resonancia Magnética	Salamanca
Spain	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona [barcelona]
Spain	ASCIRES ECG Médica S.L	València	Valenciana, Comunitat
Spain	Hospital Universitari i Politecnic La Fe	València
Sweden	Falu Lasarett	Falun
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro LÄN [se-18]
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	UCHealth Harmony	Fort Collins	Colorado
United States	Ascentist Doctor Hospital	Leawood	Kansas
United States	Alliance for Multispecialty Research, LLC	Merriam	Kansas
United States	O'Brien Pharmacy	Mission	Kansas
United States	BRCR Global	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Czechia,  Finland,  France,  Germany,  Japan,  Norway,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival per International Myeloma Working Group criteria	From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first	Up to approximately 5 years
Secondary	Overall survival	From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first	Up to approximately 5 years
Secondary	Progression free survival on next-line treatment per International Myeloma Working Group criteria	From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first	Up to approximately 5 years
Secondary	Objective response rate per International Myeloma Working Group criteria	From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy	Up to approximately 5 years
Secondary	Duration of response per International Myeloma Working Group criteria	From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first	Up to approximately 5 years
Secondary	Very good partial response or better response rate per International Myeloma Working Group criteria	From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first	Up to approximately 5 years
Secondary	Complete response rate per International Myeloma Working Group criteria	From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first	Up to approximately 5 years
Secondary	Duration of complete response per International Myeloma Working Group criteria	From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first	Up to approximately 5 years
Secondary	Time to response per International Myeloma Working Group criteria	From date of randomization to date of confirmed objective response	Up to approximately 5 years
Secondary	Minimal residual disease negativity rate per International Myeloma Working Group criteria	From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first	Up to approximately 5 years
Secondary	Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria	From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first	Up to approximately 5 years
Secondary	Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria	From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first	Up to approximately 5 years
Secondary	Frequency of treatment-emergent adverse events		From date of first dose of study intervention up to 90 days after last study intervention administration
Secondary	Frequency of abnormal laboratory results		From date of first dose of study intervention up to 90 days after last study intervention administration
Secondary	Free elranatamab serum trough concentration [Ctrough]		From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Secondary	Elranatamab immunogenicity by anti-drug antibodies against elranatamab		From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Secondary	Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30	Change from baseline scores	From date of informed consent up to approximately 35 days after last administration of study intervention
Secondary	Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20	Change from baseline scores	From date of informed consent up to approximately 35 days after last administration of study intervention

External Links

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