Daratumumab
DrugParticipants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Other names: JNJ-54767414
NCT Number: NCT04121260
The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Peking University Third Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Other names: JNJ-54767414
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.
Time frame: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
Cmax is the maximum observed serum concentration.
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.
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.
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 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).
Time frame: Up to 2 years
Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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