Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Rechercher Study Connect

Active, Not Recruiting

Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma - BB2121-MM-007

Mis à jour: 2 novembre, 2023   |   ClinicalTrials.gov

Celgene Corporation, filiale entièrement détenue par Bristol-Myers Squibb Company 

Résumé imprimable

VOUS ENVISAGEZ CET ESSAI ?
Imprimer cette page et le guide d’essai pour vous aider à parler avec votre médecin.
Utiliser le Guide du participant à l’étude pour découvrir comment participer à un essai clinique. Comprendre les principaux facteurs à envisager avant de prendre une décision et poser des questions à votre équipe soignante.

Détails de l’essai

  • Phase 1/Phase 2

    Phase

  • Sexe(s)

  • 18+

    Tranche d’âge

  • Active, Not Recruiting

Options de traitement

Bras de l’étude
INTERVENTION ASSIGNÉE
Experimental: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)
Drug: CC-220 Biological: BB2121
Experimental: Arm B- bb2121 in combination with BMS-986405 (JSMD194)
Biological: BB2121 Drug: BMS-986405

Principaux critères d’éligibilité

Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: - Participant has documented diagnosis of MM and measurable disease, defined as: 1. M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis [uPEP]): sPEP ≥ 0.5 g/dL or uPEP ≥ 200 mg/24 hours and/or 2. Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio - Participant has received: 1. at least 3 prior MM regimens for Arm A Cohort 1 and Arm B 2. at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2 and Arm C. - Arm A Cohort 1 and Arm B: Participant has received prior treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody-containing regimen for at least 2 consecutive cycles. - Arm A Cohort 2 and Arm C: Participant has received prior treatment with an immunomodulatory agent for at least 2 consecutive cycles. - Evidence of PD during or within 6 months (measured from the last dose of any drug within the regimen) of completing treatment with the last antimyeloma regimen before study entry. - Participant achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen. - Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: The presence of any of the following will exclude a participant from enrollment: - Participant has non-secretory MM or has history of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis. - Participant has any of the following laboratory abnormalities: 1. ANC and Platelets count as reported below 2. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening) 3. Creatinine clearance (CrCl) as reported below 4. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) 5. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 ×upper limit of normal (ULN) 6. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome 7. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or participant requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors) - Participant has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air. - Participant has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. - Prior exposure to CC-220 (± low-dose dexamethasone) as part of their most recent antimyeloma treatment regimen (Arm A). - Prior exposure to, BMS-986405 (JSMD194) (Arm B). - Prior exposure to DARA in combination with POM with or without dexamethasone (DP±d) as part of their most recent antimyeloma treatment regimen (Arm C Cohort 1). - Prior exposure to POM in combination with BTZ with or without dexamethasone (PV± d as part of their most recent antimyeloma treatment regimen (Arm C Cohort 2). - Previous history of an allogeneic hematopoietic stem cell transplantation, treatment with any gene therapy-based therapeutic for cancer, investigational cellular therapy for cancer or BCMA targeted therapy. - Treatment Arm A Cohort 1 and Arm B: participant has received autologous stem cell transplantation (ASCT) within 12 weeks prior to leukapheresis. - Treatment Arms A Cohort 2 and Arm C: participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis.

Nous vous recommandons vivement de contacter BMS pour signaler les effets secondaires (événements indésirables)
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici
Signaler des plaintes concernant des effets indésirables (effets indésirables) ou des produits: Informations médicales