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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 : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Private Limited

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: 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.
Drug: 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).
Other Name: DARZALEX




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Sponsors and Collaborators
Johnson & Johnson Private Limited
Investigators
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Study Director: Johnson & Johnson Private Limited Clinical Trial Johnson & Johnson Private Limited

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Responsible Party: Johnson & Johnson Private Limited
ClinicalTrials.gov Identifier: NCT03768960     History of Changes
Other Study ID Numbers: CR108556
54767414MMY4008 ( Other Identifier: Johnson & Johnson Private Limited )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antibodies, Monoclonal
Immunologic Factors
Proteasome Inhibitors
Antineoplastic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action