Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: DARZALEX (Daratumumab): Participants will receive 16 milligram per kilogram (mg/kg) of daratumumab as intravenous (IV) infusion every week (QW) in Cycles 1 and 2 (Days 1, 8, 15 and 22)
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAE)Timepoint: Approximately up to 29 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) ScoreTimepoint: Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days);Change from Baseline in EuroQol-5 Dimensions (EQ- 5D-5L) ScoreTimepoint: Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days);Overall Response Rate (ORR)Timepoint: Approximately up to 24 weeks;Percentage of Participants with Progression Free Survival (PFS)Timepoint: Approximately up to 24 weeks;Percentage of Participants with Very Good Partial Response (VGPR) or betterTimepoint: Approximately up to 24 weeks;Time to ResponseTimepoint: Approximately up to 24 weeks | — |
Countries
India
Contacts
Public ContactDr Sanish Davis
Johnson & Johnson Private Limited
Outcome results
None listed