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
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|ClinicalTrials.gov Identifier: NCT03768960|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Daratumumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||June 20, 2021|
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.
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).
Other Name: DARZALEX
- Incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Approximately up to 29 weeks ]An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug.
- Overall Response Rate (ORR) [ Time Frame: Approximately up to 24 weeks ]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.
- Percentage of Participants with Very Good Partial Response (VGPR) or better [ Time Frame: Approximately up to 24 weeks ]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.
- Percentage of Participants with Progression Free Survival (PFS) [ Time Frame: Approximately up to 24 weeks ]PFS is defined as % of participants with PFS from date of randomization to either PD, according to the IMWG criteria or death, whichever occurs first. PD: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24 hours urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24 hour; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be greater than (>)10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
- Time to Response [ Time Frame: Approximately up to 24 weeks ]Time to Response: time between the date of randomization and the first effectiveness evaluation that the participant has met all criteria for CR or PR. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5% PCs in bone marrow; PR: greater than or equal to (>=) 50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to less than (<) 200 mg/24 hours; if serum and urine M-protein are not measurable, >=50% decrease in difference between involved and uninvolved free light chains (FLC) levels; 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 percentage >=30%; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas.
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score [ Time Frame: Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days) ]The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.
- Change from Baseline in EuroQol-5 Dimensions (EQ-5D-5L) Score [ Time Frame: Baseline, Day 1 (Cycle 1 to 5); Days 1 and 28 (Cycle 6) (each cycle of 28 days) ]EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768960
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Vedanta Institute of Medical Science||Withdrawn|
|Ahmedabad, India, 380009|
|Avron Hospitals Pvt. Ltd||Not yet recruiting|
|Ahmedabad, India, 380013|
|M S Ramaiah Medical College and Hospital||Not yet recruiting|
|Bengaluru, India, 560054|
|Sparsh Hospitals & Critical Care (Pvt) Ltd||Recruiting|
|Bhubaneshwar, India, 751007|
|Post Graduate Institute of Medical Education & Research (PGIMER)||Not yet recruiting|
|Chandigarh, India, 160012|
|Apollo Hospitals||Not yet recruiting|
|Hyderabad, India, 500033|
|Basavatarakam Indo-American Hospital||Recruiting|
|Hyderabad, India, 500034|
|Tata Medical Center||Suspended|
|Kolkata, India, 700156|
|Shatabdi Super Speciality Hospital||Withdrawn|
|Mumbai Naka, India, 422005|
|All India Institute of Medical Sciences||Not yet recruiting|
|New Delhi, India, 110029|
|Deenanath Mangeshkar Hospital and Research Centre||Not yet recruiting|
|Pune, India, 411004|
|Noble Hospital Pvt Ltd||Recruiting|
|Pune, India, 411013|
|Regional Cancer Centre||Not yet recruiting|
|Thiruvananthapuram, India, 695011|
|Christian Medical College||Not yet recruiting|
|Vellore, India, 632004|
|Study Director:||Johnson & Johnson Private Limited Clinical Trial||Johnson & Johnson Private Limited|