C1071032 - MAGNETISMM-32 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
Prior diagnosis of MM (multiple myeloma) per IMWG criteria and previously received at least 1 but not more than 4 prior lines of therapy for MM including: At least 2 consecutive cycles of an anti-CD38 antibody-containing regimen in any prior line AND At least 2 consecutive cycles of a lenalidomide-containing regimen in any prior line
Documented evidence of progressive disease or failure to achieve a response to last line of MM therapy based on investigator's determination of response by IMWG criteria.
Measurable disease based on IMWG criteria as defined by at least 1 of the following (assessed by central laboratory): Serum M-protein (myeloma protein) 0.5 g/dL; Urinary M-protein excretion 200 mg/24 hours; Serum involved immunoglobulin FLC (free light chain) 10 mg/dL (100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
Corrected serum calcium 14 mg/dL (3.5 mmol/L), or free ionized calcium 6.5 mg/dL (1.6 mmol/L)
Adequate bone marrow function (ANC, platelets, hemoglobin)
ECOG (Eastern Cooperative Oncology Group) performance status <2.
Unable to receive a control therapy (must be able and willing to adhere to any applicable requirements per Single Reference Safety Document [SRSD] for at least one choice of control therapy, including contraceptive requirements, and must not meet the exclusions listed below for the choice of control therapy): unable to receive PVd if any of the following are present: Received prior pomalidomide therapy Does not meet criteria for bortezomib retreatment, (ie, must not have progressive disease during treatment or within 60 days of the last dose of a bortezomib-containing regimen) Grade 1 peripheral neuropathy with pain or Grade 2 peripheral neuropathy as defined by NCI-CTCAE v5.0 Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to enrollment Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential). unable to receive Kd if any of the following are present: Received prior carfilzomib therapy Uncontrolled hypertension unable to receive EPd if any of the following are present: Received prior pomalidomide therapy Received prior elotuzumab therapy
Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential).
Live attenuated vaccines within 4 weeks of the first dose of study intervention;
Cumulative dose of corticosteroids equivalent to 140 mg of prednisone (21 mg of dexamethasone) within the 14-day period before the first dose of study intervention, and administered for reasons other than anti-myeloma therapy
Anti-myeloma drug therapy, within 14 days of the initiation of study intervention (includes dexamethasone). Bisphosphonate use permitted.
Impaired hepatic or renal function.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Active HBV (Hepatitis B virus), HCV (Hepatitis C virus), SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), HIV [human immunodeficiency virus], or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 21 days prior to enrollment. Treatment with systemic anti-infective agents must have completed at least 28 days prior to enrollment. Prophylactic use of systemic anti-infective agents is permitted.
Ongoing Grade 3 peripheral sensory or motor neuropathy; history of GBS (Guillain-Barré syndrome) or GBS variants; history of any Grade 3 peripheral motor polyneuropathy.
Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment, including LVEF (left ventricular ejection fraction) <40% as determined by a MUGA (multigated acquisition) scan or ECHO (echocardiogram) at screening.
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
Known or suspected hypersensitivity to the study interventions or any of their excipients.
Unresolved acute effects (excluding alopecia) of any prior therapy (not resolved to baseline severity or CTCAE Grade 1).
Previous treatment with a BCMA-directed or CD3 (cluster of differentiation 3) redirecting therapy.
Individuals who have never achieved a response (partial response [PR] or better) with any treatment during the disease course.
El objetivo de este estudio es obtener información sobre el medicamento en investigación denominado elranatamab. Este estudio tiene como objetivo comparar elranatamab con otros medicamentos para el tratamiento del MM (un tipo de cáncer).
Este estudio busca participantes que:
La mitad de los participantes recibirán elranatamab. La otra mitad de los participantes recibirán una terapia combinada seleccionada por el médico del estudio. La terapia combinada seleccionada incluirá de 2 a 3 medicamentos diferentes que se utilizan comúnmente para tratar el MM.
Elranatamab se administrará mediante una inyección subcutánea en la clínica del estudio aproximadamente una vez a la semana. Esto puede cambiar a un número menor de inyecciones más adelante en el estudio.
Los medicamentos de la terapia combinada se tomarán por vía oral (en casa o en la clínica del estudio) Y se administrarán de una de las siguientes formas:
una inyección subcutánea en la clínica del estudio
a través de una aguja en la vena en la clínica del estudio El número de veces que se tomarán estos medicamentos depende de la terapia combinada que seleccione el médico del estudio.
Los participantes pueden seguir recibiendo elranatamab o una terapia combinada hasta que su MM deje de responder. El equipo del estudio evaluará cómo responde cada participante al tratamiento del estudio durante las visitas periódicas a la clínica del estudio. El equipo del estudio continuará el seguimiento de los participantes después del tratamiento mediante contactos telefónicos (o visitas).
El estudio comparará las experiencias de las personas que reciben elranatamab con las de las personas que reciben una terapia combinada. Esto ayudará a conocer la seguridad y la eficacia de elranatamab.
