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

NCT03768960 | Completed Phase 4

• 2 other identifiers: CR10855654767414MMY4008
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately up to 29 weeks

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Approximately up to 24 weeks

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

  Approximately up to 24 weeks

• Percentage of Participants with Progression Free Survival (PFS)

  Approximately up to 24 weeks

• Time to Response

  Approximately up to 24 weeks

• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

  Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days)

Study Arms (1)

Daratumumab

EXPERIMENTAL

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.

Drug: Daratumumab

Interventions

Daratumumab 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).

Also known as: DARZALEX

Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Private Limited: lead

Study Sites (16)

Avron Hospitals Pvt. Ltd

Ahmedabad, 380013, India

Location

M S Ramaiah Medical College and Hospital

Bengaluru, 560054, India

Location

Sparsh Hospitals & Critical Care (Pvt) Ltd

Bhubaneshwar, 751007, India

Location

Apollo Hospitals

Bhubaneswar, 751005, India

Location

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, 160012, India

Location

Apollo Hospitals

Hyderabad, 500033, India

Location

Basavatarakam Indo-American Hospital

Hyderabad, 500034, India

Location

Cytecare Hospitals Pvt. Ltd

Karnataka, 560064, India

Location

Tata Medical Center

Kolkata, 700156, India

Location

Shatabdi Super Speciality Hospital

Mumbai Naka, 422005, India

Location

Kingsway Hospital

Nagpur, 440001, India

Location

Apex Wellness Hospital

Nashik, 422009, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, 605008, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004, India

Location

Noble Hospital Pvt Ltd

Pune, 411013, India

Location

Related Publications (1)

• 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.

  PMID: 38116642 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Johnson & Johnson Private Limited Clinical Trial

  Johnson & Johnson Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 7, 2018
• Study Start: June 10, 2019
• Primary Completion: July 16, 2022
• Study Completion: July 16, 2022
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

IN (16)