- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242889
A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
April 13, 2023 updated by: Janssen Pharmaceutical K.K.
A Phase 1 Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM).
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gunma, Japan, 377-0280
- National Hospital Organization Shibukawa Medical Center
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Nagoya, Japan, 467-8602
- Nagoya City University Hospital
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Ohgaki, Japan, 503-8502
- Ogaki Municipal Hospital
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Osaka, Japan, 565-0871
- Osaka University Hospital
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Shibuya, Japan, 150-8935
- Japanese Red Cross Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participant proven to have Multiple Myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria
Participant must have measurable, secretory disease as defined by any of the following:
- Immunoglobulin (Ig) G MM: serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg)/24 hours; or
- IgA, IgD, IgE MM: serum M-protein level >= 0.5 g/dL or urine M-protein level >= 200 mg/24 hours; or
- Light chain MM, for participants without measurable disease in the serum or urine: serum Ig free light chains (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
- Participant must have received >= 2 prior lines of antimyeloma therapy without further established treatment option
- Participant must have relapsed or refractory disease
- Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
The Participant must meet the following criteria of clinical laboratory test results during screening phase:
- hemoglobin >=7.5 g/dL (>=5 millimoles/liter [mmol/L]) (without prior Red Blood Cells (RBC) transfusion within 7 days before the laboratory test;
- absolute neutrophil count (ANC) >=1.0*10^9/L (without granulocyte colony stimulating factor support in the 7 days prior the laboratory test);
- platelet count >=75*10^9/L for participants in whom less than (<)50.0 percent (%) of bone marrow nucleated cells are plasma cells; otherwise platelet count >=50*10^9/L (without transfusion support in the 7 days prior to the laboratory test);
- aspartate aminotransferase (AST) less than or equal to (<=)3.0 times upper limit of normal (ULN);
- alanine aminotransferase (ALT) <=3.0 times ULN;
- creatinine clearance >20 mL/minute/1.73 m^2;
- total bilirubin <=2.0 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 times ULN is required);
- corrected serum calcium <=14 mg/dL (<=3.5 mmol/L)
- Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use highly effective methods of reliable birth control. Contraception must begin 4 weeks before initiating treatment, during therapy, during dose interruptions, and continue for 6 months following discontinuation of study therapy
- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control, even if he had a successful vasectomy, for example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the final dose of study drug
Exclusion Criteria:
- Participant has received daratumumab or other anti cluster of differentiation (CD)38 therapies previously
- Participant has received antimyeloma treatment within 2 weeks before Cycle 1 Day 1
- Participant has received autologous stem cell transplantation (ASCT) within 12 weeks before Cycle 1 Day 1, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
- Participant has received a cumulative dose of corticosteroids equivalent or more than the equivalent of 140 mg of prednisolone within the 2-week period before Cycle 1 Day 1
- Participant has a history of malignancy (other than MM) within 3 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DARA SC
Participants will receive DARA SC (daratumumab 1800 milligram [mg] with Recombinant Human Hyaluronidase [rHuPH20] 30,000 units [U] that is 2000 U/milliliter [U/mL]) subcutaneous (SC) injection once weekly for the first 8 weeks in Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks in Cycles 3 to 6 (Days 1 and 15) for the following 16 weeks and then every 4 weeks (from Cycle 7 [Day 1]) in subsequent cycles until disease progression, unacceptable toxicity, or any other reason for discontinuation.
Each cycle is 28 days in duration.
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Participants will receive 1800 mg daratumumab with 30,000 U (2000 U/mL) rHuPH20 SC injection once weekly for the first 8 weeks in Cycles 1 and 2 and every 2 weeks in Cycles 3 to 6 for 16 weeks and then every 4 weeks in subsequent cycles until disease progression, unacceptable toxicity, or any other reason for discontinuation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events Including Dose Limiting Toxicity
Time Frame: Up to 30 days after last study drug dose (approximately up to 1 year)
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An adverse event (AE) is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
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Up to 30 days after last study drug dose (approximately up to 1 year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Concentration (Cmax) of Daratumumab
Time Frame: Up to 8 weeks after the last dose of study drug (approximately up to 1 year)
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Maximum observed concentration of daratumumab will be measured.
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Up to 8 weeks after the last dose of study drug (approximately up to 1 year)
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Maximum Serum Trough Concentration (Ctrough) of Daratumumab
Time Frame: At Cycle 3 Day 1 predose concentration
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Ctrough is the concentration of daratumumab prior to the next drug administration.
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At Cycle 3 Day 1 predose concentration
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Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
Time Frame: Up to 8 weeks after the last dose of study drug (approximately up to 1 year)
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Serum levels of antibodies to daratumumab and rHuPH20 will be analyzed for evaluation of potential immunogenicity.
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Up to 8 weeks after the last dose of study drug (approximately up to 1 year)
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Overall Response Rate
Time Frame: Approximately up to 1 year
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Overall Response is partial response (PR)/better as per International Myeloma Working Group (IMWG) criteria.
PR: >=50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to <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; Very good partial response: serum and urine M-component detectable by immunofixation or >=90.0%
reduction in serum M-protein and urine M-protein <100mg/24 hours; Complete response (CR):negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5.0%
PCs in bone marrow; Stringent complete response (sCR): CR plus normal FLC ratio and absence of clonal PCs.
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Approximately up to 1 year
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Duration of Response (DOR)
Time Frame: First documentation of confirmed PR or better to the date of first documented progressive disease (PD), or date of death due to PD, whichever occurs first (approximately up to 1 year)
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DOR is date of first documentation of confirmed PR or better to date of first documented PD (as per IMWG criteria), or date of death due to PD, whichever occurs first.
PD: 25% increase from lowest response value in 1 of following: serum M-component, urine M-component (absolute increase must be >= 0.5 gram per deciliter [g/dL], >= 200 mg/24 hours respectively), Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase must be >10 milligram per deciliter (mg/dL), only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) attributed solely to PC proliferative disorder.
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First documentation of confirmed PR or better to the date of first documented progressive disease (PD), or date of death due to PD, whichever occurs first (approximately up to 1 year)
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Time to Response
Time Frame: Approximately up to 1 year
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Time to response is defined as the time between Cycle 1 Day 1 and the first efficacy evaluation date that the participant has met all criteria for PR or better (as per IMWG criteria).
PR: >=50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to <200 mg/24 hours; if serum and urine M-protein are not measurable, >=50% decrease in difference between involved and uninvolved FLC levels; if serum and urine M-protein and serum free light assay is not measurable, >=50% reduction in bone marrow PC, with baseline bone marrow PC percentage >=30%; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas; Very good partial response: serum and urine M-component detectable by immunofixation or >=90.0%
reduction in serum M-protein and urine M-protein <100mg/24 hours; CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5.0%
PCs in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs.
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Approximately up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2017
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
February 10, 2023
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 4, 2017
First Posted (Actual)
August 8, 2017
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- CR108337
- 54767414MMY1008 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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