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

NCT ID: NCT03768960

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2022-07-16

Brief Summary

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Daratumumab

Intervention Type: DRUG

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).

Interventions

Daratumumab

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).

Intervention Type: DRUG

Other Intervention Names

DARZALEX

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Private Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Private Limited Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Private Limited

Locations

Avron Hospitals Pvt. Ltd

Ahmedabad, , India

M S Ramaiah Medical College and Hospital

Bengaluru, , India

Sparsh Hospitals & Critical Care (Pvt) Ltd

Bhubaneshwar, , India

Apollo Hospitals

Bhubaneswar, , India

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, , India

Apollo Hospitals

Hyderabad, , India

Basavatarakam Indo-American Hospital

Hyderabad, , India

Cytecare Hospitals Pvt. Ltd

Karnataka, , India

Tata Medical Center

Kolkata, , India

Shatabdi Super Speciality Hospital

Mumbai Naka, , India

Kingsway Hospital

Nagpur, , India

Apex Wellness Hospital

Nashik, , India

All India Institute of Medical Sciences

New Delhi, , India

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, , India

Deenanath Mangeshkar Hospital and Research Centre

Pune, , India

Noble Hospital Pvt Ltd

Pune, , India

Countries

India

References

Kumar L, Melinkeri S, Ganesan P, Kumar J, Biswas G, Kilara N, Pathalingappa H, Prasad S, Jain M, Mishra SK, Prasad S, Boyella PK, Sahoo RK, Bondarde S, Shah S, Rege M, Deb U, Korde T, Dixit J. Daratumumab in Indian patients with relapsed and refractory multiple myeloma: a prospective, multicenter, phase IV study. Future Oncol. 2024 Feb;20(4):191-205. doi: 10.2217/fon-2023-0842. Epub 2023 Dec 20.

Reference Type: DERIVED

PMID: 38116642 (View on PubMed)

Other Identifiers

54767414MMY4008

Identifier Type: OTHER

Identifier Source: secondary_id

CR108556

Identifier Type: -

Identifier Source: org_study_id