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)

JRCT ID: jRCT2021230055

Registered date:26/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 04/04/2024
• Target sample size: 492
• Countries of recruitment: Argentina,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 type: Interventional

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 Outcome

Primary Outcome Measures :
Progression free survival per International Myeloma Working Group criteria [ Time Frame: Up to approximately 5 years ]

Secondary Outcome

Secondary 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 maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06152575