A Prospective, Single-Arm, Multicenter, Pragmatic Phase-IV Trial Investigating Safety and Effectiveness of DARZALEX (Daratumumab) In Indian Subjects With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

Johnson and Johnson Private Limited0 个研究点目标入组 150 人开始时间: 待定最近更新: 2023年10月16日

试验速览

暂无简介。

•1. Subject of either sex and =18 years of age
•2. Subject with relapsed and refractory multiple myeloma (as per IMWG definitions) whose prior therapy included a proteasome inhibitor and an immunomodulatory agent, being newly initiated on DARZALEXTM (daratumumab) monotherapy based on independent clinical judgment of treating physicians as per locally approved prescribing information
•3. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF).

•1. Subject who are not eligible to receive DARZALEXTM as per the locally approved prescribing information.
•2. Subject participating or planning to participate in any interventional drug trial during the course of this study.
•3. Known seropositive for human immunodeficiency virus (HIV)
•4. seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND
•a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
•5. Known seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).

发起方