UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031220
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)

Acronym

DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)

Scientific Title

DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)

Scientific Title:Acronym

DARZALEX intravenous drip infusion 100 mg, 400 mg Special Drug Use Results Survey (Recurrent or refractory multiple myeloma)

Region

Japan


Condition

Condition

Recurrent or refractory multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and effectiveness of DARZALEX intravenous drip infusion in long-term actual clinical use in patients with recurrent or refractory multiple myeloma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety(Adverse Drug Reaction)
Effectiveness

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All patients with recurrent or refractory multiple myeloma who received DARZALEX

Key exclusion criteria

NA

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Koyama

Organization

Janssen Pharmaceutical K.K.

Division name

Safety Risk Management Dept.

Zip code

101-0065

Address

5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

TEL

03-4411-5478

Email

tkoyama4@ITS.JNJ.com


Public contact

Name of contact person

1st name Keiko
Middle name
Last name Imai

Organization

Janssen Pharmaceutical K.K.

Division name

Safety Risk Management Dept.

Zip code

101-0065

Address

5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

TEL

03-4411-5136

Homepage URL


Email

kimai4@ITS.JNJ.com


Sponsor or person

Institute

Janssen Pharmaceutical K.K.

Institute

Department

Personal name



Funding Source

Organization

Janssen Pharmaceutical K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Janssen Pharmaceutical K.K.

Address

5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

Tel

03-4411-5136

Email

kimai4@ITS.JNJ.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 09 Day


Related information

URL releasing protocol

-

Publication of results

Unpublished


Result

URL related to results and publications

-

Number of participants that the trial has enrolled

1036

Results

There were no observed predictors of a safety and efficacy issue of DARZALEX in patients with recurrent or refractory multiple myeloma.

Results date posted

2023 Year 02 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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).

Participant flow

All patients with recurrent or refractory multiple myeloma who received DARZALEX between the approval date of DARZALEX and March 31, 2018 were included.

Adverse events

The incidence rate of ADRs was 68.07% (663/974 patients).

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 09 Month 26 Day

Date of IRB

2017 Year 09 Month 26 Day

Anticipated trial start date

2017 Year 11 Month 22 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 10 Month 31 Day

Date trial data considered complete

2021 Year 11 Month 15 Day

Date analysis concluded

2022 Year 02 Month 15 Day


Other

Other related information

Special Drug-Use Results Survey


Management information

Registered date

2018 Year 02 Month 09 Day

Last modified on

2023 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name