Clinical trial NCT03768960: 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
Official title: A Prospective, Single-Arm, Multicenter, Pragmatic Phase-IV Trial Investigating Safety and Effectiveness of DARZALEX (Daratumumab) In Indian Subjects With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Myeloma
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAE)
timeFrame: Approximately up to 29 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately up to 24 weeks
measure: Percentage of Participants with Very Good Partial Response (VGPR) or better
timeFrame: Approximately up to 24 weeks
measure: Percentage of Participants with Progression Free Survival (PFS)
timeFrame: Approximately up to 24 weeks
measure: Time to Response
timeFrame: Approximately up to 24 weeks
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days)
measure: Change from Baseline in EuroQol-5 Dimensions (EQ-5D-5L) Score
timeFrame: Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days)
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Avron Hospitals Pvt. Ltd
city: Bengaluru
country: India
facility: M S Ramaiah Medical College and Hospital
city: Bhubaneshwar
country: India
facility: Sparsh Hospitals & Critical Care (Pvt) Ltd
city: Bhubaneswar
country: India
facility: Apollo Hospitals
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education And Research PGIMER
city: Hyderabad
country: India
facility: Apollo Hospitals
city: Hyderabad
country: India
facility: Basavatarakam Indo-American Hospital
city: Karnataka
country: India
facility: Cytecare Hospitals Pvt. Ltd
city: Kolkata
country: India
facility: Tata Medical Center
city: Mumbai Naka
country: India
facility: Shatabdi Super Speciality Hospital
city: Nagpur
country: India
facility: Kingsway Hospital
city: Nashik
country: India
facility: Apex Wellness Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Pondicherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Pune
country: India
facility: Noble Hospital Pvt Ltd
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: