A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04121260|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Daratumumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma|
|Estimated Study Start Date :||March 13, 2020|
|Estimated Primary Completion Date :||July 20, 2021|
|Estimated Study Completion Date :||July 20, 2022|
Participants will receive daratumumab dose 1 subcutaneously (SC) with recombinant human hyaluronidase [rHuPH20] 30,000 units [U] that is 2,000 U/milliliter (U/mL) SC injection once weekly for the first 8 weeks Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks Cycles 3 to 6 (Days 1 and 15) or 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.
Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Other Name: JNJ-54767414
- Number of participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Up to 2 years ]An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non‑investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Maximum Observed Serum Concentration (Cmax) of Daratumumab [ Time Frame: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days) ]Cmax is the maximum observed serum concentration.
- Serum Trough Concentration (Ctrough) of Daratumumab [ Time Frame: At Day 1 Cycle 3 predose concentration (each cycle is of 28 days) ]Ctrough is the observed concentration of daratumumab prior to the next drug administration.
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR, defined as the percentage of participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) response criteria.
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]DOR, defined as date of onset of first response until date of disease progression or death (according to the IMWG response criteria).
- Time to Response [ Time Frame: Up to 2 years ]TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).
- Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies [ Time Frame: Up to 2 years ]Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.
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): NCT04121260
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Peking University Third Hospital||Not yet recruiting|
|Beijing, China, 100191|
|The Third Xiangya Hospital, Central South University||Not yet recruiting|
|Changsha, China, 410013|
|Nanfang Hospital||Not yet recruiting|
|Guangzhou, China, 510515|
|Nanjing Drum Tower Hospital||Not yet recruiting|
|Nanjing, China, 210008|
|Zhongda Hospital,Southeast University||Not yet recruiting|
|Nanjing, China, 210009|
|Institute of Hematology & Blood Diseases Hospital||Not yet recruiting|
|Tianjin, China, China, 300320|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|