A PHASE 1/2 DOSE ESCALATION SAFETY, PHARMACOKINETIC AND EFFICACY STUDY OF MULTIPLE INTRAVENOUS ADMINISTRATIONS OF A HUMANIZED MONOCLONAL ANTIBODY (SAR650984) AGAINST CD38 IN PATIENTS WITH SELECTED CD38+ HEMATOLOGICAL MALIGNANCIES

Sanofi Aventis Recherche & Development,0 个研究点目标入组 3 人开始时间: 2017年2月9日最近更新: 2023年11月13日

适应症

试验速览

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•1-Diagnosis of multiple myeloma with evidence of measurable disease, and have evidence of disease progression based on International Myeloma Working Group criteria (IMWG) 2-Patients must have received prior treatment with an IMiD (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment) 3-Have received at least three prior lines of therapy (Appendix C of protocol) for multiple myeloma. Induction therapy and stem cell transplant (± maintenance) will be considered as one line OR Patients whose disease is double refractory to an IMID and a PI. For patients who have received more than one type of IMiD and PI, their disease must be refractory to the most recent one. Refractory disease is defined as a disease that is progressive while being on treatment, or progressive within 60 days of the last administration of these therapies or never reached at least a MR with those drugs 4-Patients must have achieved an MR or better to at least one prior line of therapy 5-Patients must have received an alkylating agent (for ≥2 cycles or ≥2 months of treatment) either alone or in combination with other MM treatments (history of stem cell transplant is acceptable). 6-Signed written informed consent and be willing and able to complete all studyrelated procedures

•1-Be <18 years old 2-Multiple myeloma IgM subtype 3-Previous treatment with any anti-CD38 therapy 4-Concurrent plasma cell leukemia 5-Patients with known or suspected amyloidosis 6-Patients treated with approved or investigative anticancer therapeutic agents (excluding dexamethasone), within 3 weeks or within five drug half-lives (t1/2) prior to first dose, whichever time is greater 7-Patients treated with systemic radiation therapy within 4 weeks prior to first dose or localized radiation therapy within 1 week prior to first dose 8-Patients who have had major surgery within 3 weeks prior to first dose 9-Poor bone marrow reserve 10-Patients ECOG Performance status >2 11-Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results. 12-Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results. 13-Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of study therapy that is not amenable to pre-medication with steroids and H2 blockers

发起方

Sanofi Aventis Recherche & Development,