A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Multiple Myeloma

Treatments: Drug: Daratumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03768960

54767414MMY4008 (Other Identifier)

CR108556

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety profile of daratumumab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with relapsed and refractory multiple myeloma (as per International Myeloma Working Group [IMWG] definitions) whose prior therapy included a proteasome inhibitor and an immunomodulatory agent, being newly initiated on DARZALEX (daratumumab) monotherapy based on independent clinical judgment of treating physicians as per locally approved prescribing information
• Each participant (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. Participants 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

• Participants who are not eligible to receive DARZALEX as per the locally approved prescribing information
• Participant participating or planning to participate in any interventional drug trial during the course of this study
• Known seropositive for human immunodeficiency virus (HIV)
• Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (that is, participants 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) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. exception: Participants 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
• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

Daratumumab

Experimental group

Description:

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) and every 2 weeks (Q2W) in Cycle 3 to 6 (Days 1 and 15) each cycle is of 28 days.

Treatment:

Drug: Daratumumab