The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Peking University Third Hospital
Beijing, China
The Third Xiangya Hospital, Central South University
Changsha, China
Nanfang Hospital
Guangzhou, China
Zhongda Hospital,Southeast University
Nanjing, China
Number of participants with Adverse Events (AEs) and Serious AEs
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: Up to 2 years
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Cmax is the maximum observed serum concentration.
Time frame: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
Serum Trough Concentration (Ctrough) of Daratumumab
Ctrough is the observed concentration of daratumumab prior to the next drug administration.
Time frame: At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)
Overall Response Rate (ORR)
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
Duration of Response (DOR)
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
Time to Response
TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).
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Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Time frame: Up to 2 years
Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.
Time frame: Up to 2 years