UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041478
Receipt number R000047347
Scientific Title Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)
Date of disclosure of the study information 2020/08/31
Last modified on 2026/08/05 10:39:50

* 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

Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)

Acronym

Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)

Scientific Title

Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)

Scientific Title:Acronym

Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)

Region

Japan


Condition

Condition

Relapsed or refractory multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To collect the safety and effectiveness information of use of Sarclisa in Japanese patients with relapsed or refractory multiple myeloma.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety (Adverse Drug Reaction)

Key secondary outcomes

Effectiveness


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

Patients who will receive the treatment with Sarclisa.

Key exclusion criteria

NA

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name TAMURA

Organization

Sanofi K.K.

Division name

Post-authorization regulatory studies, Medical Affairs

Zip code

163-1488

Address

3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo

TEL

03-6301-3867

Email

Sanofi_Medical@sanofi.com


Public contact

Name of contact person

1st name Public contact for Drug use surveillance
Middle name
Last name -

Organization

Sanofi K.K.

Division name

Post-authorization regulatory studies, Medical Affairs

Zip code

163-1488

Address

3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo

TEL

03-6301-3867

Homepage URL


Email

Sanofi_Medical@sanofi.com


Sponsor or person

Institute

Sanofi K.K.

Institute

Department

Personal name



Funding Source

Organization

Sanofi 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

-

Address

-

Tel

-

Email

-


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

2020 Year 08 Month 31 Day


Related information

URL releasing protocol

NA

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s12185-024-03800-5

Number of participants that the trial has enrolled

211

Results

In the safety analysis set (n=120), ADR incidence was 57.5% with serious ADRs in 28.3%. Bone marrow suppression occurred in 46.7% (19.2% serious), infusion reactions in 18.3% (6.7% serious), infections in 11.7% (8.3% serious), one serious cardiac disorder, and Grade>=3 ADRs in 3.3% (1.7% serious). In the effectiveness analysis set (n=108), ORR was 51.9% and VGPR was 24.1%. These findings support Isa-Pd safety and effectiveness for RRMM in real-life Japanese settings.

Results date posted

2026 Year 08 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The majority of participants in the safety analysis set were Japanese (99.2%) and inpatients (90.8%), and 59.2% of participants were male. The mean age+/-SD was 70.2+/-9.2 years, and the majority of participants (74.2%) were >= 65 years old. ISS staging was Stage II in 36.7% and Stage III in 35.8%; R-ISS staging was Stage II in 39.2% and Stage III in 25.0%. ECOG performance status was 0 in 20.8% and 1 in 42.5% of participants. Current medical complications included hepatic dysfunction (5.0%), renal impairment (11.7%), and other complications (54.2%). The mean+/-SD duration of isatuximab treatment was 182.5+/-144.2 days. Of the 120 participants included in the safety analysis set, 32 (26.7%) completed>=12 months of observation, while follow-up ended before this time in 88 (73.3%), most commonly because of primary disease progression (n=47;39.2%).

Participant flow

The registry was initiated (first participant registered) on October 20, 2020; the completion date (last participant completed) was April 19, 2022. In total, 211 individuals from 122 sites were registered. Of the 122 individuals from whom consent for publication was obtained, 120 were included in the safety analysis. 108 individuals were included in the effectiveness analysis set.

Adverse events

In the safety analysis set, ADRs were observed in 69 participants (57.5%). The most common ADRs were neutrophil count decreased (n=31;25.8%), platelet count decreased (n=15;12.5%), anemia (n=12;10.0%), neutropenia (n=9;7.5%), and white blood cell count decreased (n=9;7.5%). Serious ADRs were observed in 34 participants (28.3%), with the most common being neutropenia (n=9;7.5%), neutrophil count decreased (n=6;5.0%), febrile neutropenia(n=6;5.0%), pneumonia (n=4;3.3%), and white blood cell count decreased (n=4;3.3%). ADRs of special interest included bone marrow suppression in 56 participants (46.7%), infusion reactions in 22 participants (18.3%), infections in 14 participants (11.7%), and cardiac disorder in 1 participant (0.8%).Other Grade>=3 ADRs of special interest were reported in four participants (3.3%). In two of these participants (1.7%), the ADRs were considered serious (hypercalcemia and hepatic function abnormal).

Outcome measures

Incidence of adverse drug reactions (ADRs), defined as adverse events for which a causal relationship with isatuximab could not be ruled out. The incidence of ADRs of special interest (infusion reactions, bone marrow suppression, infections, and cardiac disorders), other Grade>=3 ADRs of special interest, and serious ADRs were assessed. The effectiveness of isatuximab was assessed using the International Myeloma Working Group (IMWG) response criteria at the end of the final cycle of treatment. Response was classified as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) and the overall response rate (sCR+CR+VGPR+PR) were determined.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 07 Month 31 Day

Date of IRB

2020 Year 07 Month 31 Day

Anticipated trial start date

2020 Year 10 Month 20 Day

Last follow-up date

2022 Year 04 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Special Drug Use Investigation


Management information

Registered date

2020 Year 08 Month 20 Day

Last modified on

2026 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047347