Multiple Myeloma
Conditions
Keywords
Elranatamab, B-Cell Maturation Antigen, BCMA, Bispecific antibody, BCMA-CD3 bispecific antibody, Myeloma, Multiple myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, MagnetisMM, MagnetisMM-32, Pomalidomide, Elotuzumab, Bortezomib, Carfilzomib, PF-06863135
Brief 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.
Interventions
DRUGElranatamab
Elranatamab will be administered subcutaneously
DRUGElotuzumab
Elotuzumab will be administered intravenously
DRUGPomalidomide
Pomalidomide will be administered orally
DRUGDexamethasone
Dexamethasone will be administered orally
DRUGBortezomib
Bortezomib will be administered subcutaneously or intravenously
DRUGCarfilzomib
Carfilzomib will be administered intravenously
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 | From date of informed consent up to approximately 35 days after last administration of study intervention | Change from baseline scores |
| Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 | From date of informed consent up to approximately 35 days after last administration of study intervention | Change from baseline scores |
| Frequency of abnormal laboratory results | From date of first dose of study intervention up to 90 days after last study intervention administration | — |
| Overall survival | Up to approximately 5 years | From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first |
| Progression free survival on next-line treatment per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first |
| Objective response rate per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy |
| Duration of response per International Myeloma Working Group criteria | Up to approximately 5 years | From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first |
| Very good partial response or better response rate per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first |
| Complete response rate per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first |
| Duration of complete response per International Myeloma Working Group criteria | Up to approximately 5 years | From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first |
| Time to response per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of confirmed objective response |
| Minimal residual disease negativity rate per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first |
| Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria | Up to approximately 5 years | From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first |
| Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria | Up to approximately 5 years | From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first |
| Free elranatamab serum trough concentration [Ctrough] | From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab | — |
| Frequency of treatment-emergent adverse events | From date of first dose of study intervention up to 90 days after last study intervention administration | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed