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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
National Hospital Organization Shibukawa Medical Center
Gunma, Japan
Nagoya City University Hospital
Nagoya, Japan
Ogaki Municipal Hospital
Ohgaki, Japan
Osaka University Hospital
Osaka, Japan
Number of Participants With Adverse Events Including Dose Limiting Toxicity
An adverse event (AE) is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Time frame: Up to 30 days after last study drug dose (approximately up to 1 year)
Maximum Observed Concentration (Cmax) of Daratumumab
Maximum observed concentration of daratumumab will be measured.
Time frame: Up to 8 weeks after the last dose of study drug (approximately up to 1 year)
Maximum Serum Trough Concentration (Ctrough) of Daratumumab
Ctrough is the concentration of daratumumab prior to the next drug administration.
Time frame: At Cycle 3 Day 1 predose concentration
Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
Serum levels of antibodies to daratumumab and rHuPH20 will be analyzed for evaluation of potential immunogenicity.
Time frame: Up to 8 weeks after the last dose of study drug (approximately up to 1 year)
Overall Response Rate
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Japanese Red Cross Medical Center
Shibuya City, Japan
Time frame: Approximately up to 1 year
Duration of Response (DOR)
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.
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)
Time to Response
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.
Time frame: Approximately up to 1 year