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 Private Limited150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Multiple Myeloma

Interventions

DaratumumabDRUG

Participants will receive 16 mg/kg of daratumumab as IV infusion QW in Cycles 1 and 2 (Days 1, 8, 15 and 22) and Q2W in Cycle 3 to 6 (Days 1 and 15).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (16)

Avron Hospitals Pvt. Ltd

Ahmedabad, India

M S Ramaiah Medical College and Hospital

Bengaluru, India

Apollo Hospitals

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events (TEAE)

An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug.

Time frame: Approximately up to 29 weeks

Secondary Outcomes

Overall Response Rate (ORR)

ORR- % of participants who achieve partial response (PR) or better per IMWG criteria during study treatment. PR: \>=50% reduction of serum M-protein, \>=90% reduction in 24 hour urinary M-protein or to\<200mg/24hour; if serum and urine M-protein are not measurable, \>=50% decrease in difference between involved and uninvolved free light chain (FLC) level; if serum and urine M-protein and serum free light assay is not measurable, \>=50% reduction in bone marrow plasma cell (PC), with baseline bone marrow PC% \>=30%; if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas; VGPR: serum and urine M-component detectable by immunofixation or \>=90% reduction in serum M-protein and urine M-protein \<100mg/24hour; Complete response(CR):negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

Time frame: Approximately up to 24 weeks

Percentage of Participants with Very Good Partial Response (VGPR) or better

VGPR or better is defined as percentage (%) of participants with a response of very good partial response (VGPR) or better according to the International Myeloma Working Group (IMWG) criteria, during the study treatment. IMWG criteria for VGPR: serum and urine M-component detectable by immunofixation or greater than or equal to (\>=)90% reduction in serum M-protein and urine M-protein less than (\<)100 milligram(mg)/24hour; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; Stringent CR (sCR): CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

Time frame: Approximately up to 24 weeks

Data from ClinicalTrials.gov

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