Unique ID issued by UMIN | UMIN000031220 |
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Receipt number | R000035652 |
Scientific Title | DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma) |
Date of disclosure of the study information | 2018/02/09 |
Last modified on | 2023/08/15 11:44:16 |
DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)
DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)
DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)
DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)
Japan |
Recurrent or refractory multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
To investigate safety and effectiveness of DARZALEX intravenous drip infusion in long-term actual clinical use in patients with recurrent or refractory multiple myeloma.
Safety,Efficacy
Safety(Adverse Drug Reaction)
Effectiveness
Observational
Not applicable |
Not applicable |
Male and Female
All patients with recurrent or refractory multiple myeloma who received DARZALEX
NA
300
1st name | Takeshi |
Middle name | |
Last name | Koyama |
Janssen Pharmaceutical K.K.
Safety Risk Management Dept.
101-0065
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5478
tkoyama4@ITS.JNJ.com
1st name | Keiko |
Middle name | |
Last name | Imai |
Janssen Pharmaceutical K.K.
Safety Risk Management Dept.
101-0065
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5136
kimai4@ITS.JNJ.com
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Profit organization
Janssen Pharmaceutical K.K.
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5136
kimai4@ITS.JNJ.com
NO
2018 | Year | 02 | Month | 09 | Day |
-
Unpublished
-
1036
There were no observed predictors of a safety and efficacy issue of DARZALEX in patients with recurrent or refractory multiple myeloma.
2023 | Year | 02 | Month | 13 | Day |
Of the 974 patients in the safety analysis data set, 31.52% (307/974 patients) were still on survey drug treatment at the last observation. The proportion of patients who discontinued survey drug during the observation period was 68.48% (667/974 patients). The most common reason for discontinuation was lack of efficacy in 36.04% (351/974 patients), followed by adverse events (including progression/worsening of underlying disease and death) in 19.82% (193/974 patients).
All patients with recurrent or refractory multiple myeloma who received DARZALEX between the approval date of DARZALEX and March 31, 2018 were included.
The incidence rate of ADRs was 68.07% (663/974 patients).
In this survey, the response rates at 12 and 52 weeks after the start of the survey drug were 54.05% (374/692 patients) and 59.25% (471/795 patients). When examined by combination regimen at the start of treatment, the response rates by 52 weeks were 62.80% (309/492 patients) for DARZALEX, lenalidomide and dexamethasone and 53.64% (162/302 patients) for DARZALEX, bortezomib and dexamethasone.
Completed
2017 | Year | 09 | Month | 26 | Day |
2017 | Year | 09 | Month | 26 | Day |
2017 | Year | 11 | Month | 22 | Day |
2019 | Year | 03 | Month | 31 | Day |
2021 | Year | 10 | Month | 31 | Day |
2021 | Year | 11 | Month | 15 | Day |
2022 | Year | 02 | Month | 15 | Day |
Special Drug-Use Results Survey
2018 | Year | 02 | Month | 09 | Day |
2023 | Year | 08 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035652
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