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Participant must be at least 18 years of age or of the country's legal age of |
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majority if the legal age is >18 years old, at the time of signing the |
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informed consent |
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Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group |
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(ECOG) performance status 2 |
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RRMM patients |
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must have received at least 3 prior lines of therapy including proteasome |
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inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb; and must |
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have received their last dose of prior anti-CD38 therapy within 9 months prior |
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to the first dose of SAR442257; and must be refractory to anti-CD38 antibody |
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(eg, daratumumab or isatuximab), characterized by progression within 60 days |
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of the last dose of anti-CD38, regardless of which line it was given; and must |
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be either relapsed or refractory to all established therapies with known |
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clinical benefit in RRMM where approved and available, or are intolerant to |
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those established therapies; and must not be candidates for regimens known to |
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provide clinical benefit |
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Patients with RRMM must have measurable disease as per the following |
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Serum M protein 0.5 g/dL (5 g/L), or |
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Urine M protein 200 mg/24 hours, or |
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Serum free light chain (FLC) assay: involved FLC assay 10 mg/dL and an abnormal serum FLC ratio (<0.26 or >1.65) |
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Patients with RR-NHL must be relapsed or refractory to all established |
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therapies with known clinical benefit where approved and available, or are |
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intolerant to those established therapies |
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Patients with RR-NHL must have measurable disease of at least one lesion 1.5 |
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cm as documented by computed tomography (CT) scan, including the following |
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subtype of disease |
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Diffuse large B-cell lymphoma (DLBCL) |
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transformed follicular lymphoma (tFL) |
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follicular lymphoma (FL) |
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mantle cell lymphoma (MCL) |
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marginal zone lymphoma (MZL) |
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lymphoplasmacytic lymphoma |
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small lymphocytic lymphoma (SLL). Patients with RR-NHL subtype T cell lymphoma (TCL): histopathologically confirmed mycosis fungoides or Szary syndrome (cutaneous T cell lymphoma [CTCL] stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (ie, refractory) as determined by the Investigator |
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Patients with lymphoma must have availability of lymphoma tissue for biomarker |
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testing: either archived tissue or a fresh biopsy as a part of screening. On- |
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treatment biopsy (Cycle 2 or beyond) is also expected if disease location is |
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in a superficial lymph node. Excisional biopsy or resected tissue is required |
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if clinically feasible; otherwise, core needle biopsy is acceptable. Fine |
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needle aspirates are not acceptable |
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Patients with lymphoma must have a 50% left ventricular ejection fraction |
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(LVEF) and no pericardial effusion, as measured by echocardiogram (ECHO) |
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Contraceptive use by men or women should be consistent with local regulations |
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regarding the methods of contraception for those participating in clinical |
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studies |
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Diagnosed or treated for another malignancy within 3 years prior to
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enrollment, except for basal cell carcinoma or squamous cell carcinoma of the
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skin, an in-situ malignancy, superficial bladder carcinoma or low risk
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prostate cancer
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Amyloidosis, leukemic manifestations of lymphoma, chronic lymphocytic leukemia
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and Richter's transformation, and prolymphocytic leukemia
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Known central nervous system (CNS) involvement by myeloma, lymphoma or other
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CNS disease such as neurodegenerative condition or CNS movement disorder
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Has congestive heart failure (New York Heart Association) Grade II
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cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition
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such as angina pectoris, clinically significant arrhythmia requiring therapy
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including anticoagulants, or clinically significant uncontrolled hypertension
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QT interval corrected by the Fridericia method >480 msec (Grade 2). Acute
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myocardial infarction within 6 months before start of study treatment
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Has active autoimmune disease including autoimmune hemolytic anemia
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idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis
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or any chronic condition requiring a higher corticosteroid systemic equivalent
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than prednisone 10 mg daily
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Clinically-not controlled chronic or ongoing infectious disease requiring
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treatment at the time of first dose or within the 14 days before first dose
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Active hepatitis A, B, and C as defined below: active hepatitis A (defined as
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positive IgM), active hepatitis B (defined as either positive hepatitis B
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surface antigen or positive hepatitis B viral DNA test above the lower limit
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of detection of the assay, and hepatitis B core antibodies), or C infection
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(defined as a known positive hepatitis C antibody result and known
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quantitative hepatitis C [HCV] ribonucleic acid [RNA] results greater than the
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lower limits of detection of the assay)
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Known positivity for Human Immunodeficiency Virus (HIV). Unresolved toxicities
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from prior anticancer therapy, defined as not having resolved to Common
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Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 1 or to
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levels dictated in the eligibility criteria with the exception of Grade 1
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peripheral neuropathy, alopecia or toxicities from prior anticancer therapy
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that are considered irreversible (defined as having been present and stable
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for >4 weeks) which may be allowed if they are not otherwise described in the
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exclusion criteria
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Participant not suitable for participation, whatever the reason, as judged by
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the Investigator, including medical or clinical conditions, or participants
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potentially at risk of noncompliance to study procedures
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Sensitivity to any of the study interventions, or components thereof, or drug
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or other allergy that, in the opinion of the Investigator, contraindicates
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participation in the study
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The above information is not intended to contain all considerations relevant
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to a patient's potential participation in a clinical trial
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