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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2021230055

Registered date:26/01/2024

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)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMultiple Myeloma
Date of first enrollment04/04/2024
Target sample size492
Countries of recruitmentArgentina,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Norway,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
Study typeInterventional
Intervention(s)Drug: Elranatamab Elranatamab will be administered subcutaneously Drug: Elotuzumab Elotuzumab will be administered intravenously Drug: Pomalidomide Pomalidomide will be administered orally Drug: Dexamethasone Dexamethasone will be administered orally Drug: Bortezomib Bortezomib will be administered subcutaneously or intravenously Drug: Carfilzomib Carfilzomib will be administered intravenously

Outcome(s)

Primary OutcomePrimary Outcome Measures : Progression free survival per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ]
Secondary OutcomeSecondary Outcome Measures : 1. Overall survival [ Time Frame: Up to approximately 5 years ] 2. Progression free survival on next-line treatment per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 3. Objective response rate per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 4. Duration of response per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 5. Very good partial response or better response rate per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 6. Complete response rate per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 7. Duration of complete response per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 8. Time to response per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 9. Minimal residual disease negativity rate per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 10. Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 11. Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ] 12. Frequency of treatment-emergent adverse events [ Time Frame: From date of first dose of study intervention up to 90 days after last study intervention administration ] 13. Frequency of abnormal laboratory results [ Time Frame: From date of first dose of study intervention up to 90 days after last study intervention administration ] 14. Free elranatamab serum trough concentration [Ctrough] [ Time Frame: From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab ] 15. Elranatamab immunogenicity by anti-drug antibodies against elranatamab [ Time Frame: From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab ] 16. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [ Time Frame: From date of informed consent up to approximately 35 days after last administration of study intervention ] 17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [ Time Frame: From date of informed consent up to approximately 35 days after last administration of study intervention ]

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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-protei>=n 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.
Exclude 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 Information

Contact

Public contact
Name Clinical Trials Information Desk
Address Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo Tokyo Japan 151-8589
Telephone +81-3-5309-7000
E-mail clinical-trials@pfizer.com
Affiliation Pfizer R&amp;D Japan G.K.
Scientific contact
Name Norisuke Kawai
Address Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo Tokyo Japan 151-8589
Telephone +81-3-5309-7000
E-mail clinical-trials@pfizer.com
Affiliation Pfizer R&amp;D Japan G.K.