UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061790 |
|---|---|
| Receipt number | R000070458 |
| Scientific Title | A Global Real World Platform Study Evaluating Teclistamab or Talquetamab as Primary Treatment for Patients with Relapsed or Refractory Multiple Myeloma who are Triple class Exposed in the Prior Lines of Therapy |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 18:56:24 |
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Basic information
Public title
A Global Real World Platform Study Evaluating Teclistamab or Talquetamab as Primary Treatment for Patients with Relapsed or Refractory Multiple Myeloma who are Triple class Exposed in the Prior Lines of Therapy
Acronym
CoMMitmenTT
Scientific Title
A Global Real World Platform Study Evaluating Teclistamab or Talquetamab as Primary Treatment for Patients with Relapsed or Refractory Multiple Myeloma who are Triple class Exposed in the Prior Lines of Therapy
Scientific Title:Acronym
CoMMitmenTT
Region
| Japan | South America | Europe |
Condition
Condition
Patients with Relapsed or Refractory Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the real-world effectiveness, safety, treatment patterns (including dosing and sequencing), and healthcare resource utilization (HCRU) of teclistamab (Tec) and talquetamab (Tal) in a global cohort of patients with relapsed/refractory multiple myeloma (RRMM).
Basic objectives2
Others
Basic objectives -Others
Related HCRU
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The patient characteristics, treatment patterns, and associated outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Has a confirmed diagnosis of RRMM
2. Treated with Teclistamab (Tec) or (Tal) (for Tec and Tal cohorts, respectively) after commercial launch date in each country
3. Received at least one full dose of cohort treatment (for the Tec and Tal cohorts, respectively), with the cohort treatment as monotherapy
4. Aged at least 18 years at initiation of Tec or Tal (for the Tec and Tal cohorts, respectively)
5. Had >= 1 month follow-up from the initiation of Tec or Tal (for the Tec and Tal cohorts, respectively). Patients will be eligible if they died within 1 month of Tec or Tal initiation (for the Tec and Tal cohorts, respectively). Patients are not required to be on Tec or Tal for >= 1 month (for the Tec and Tal cohorts, respectively).
6. Patients whose consent to participate in this study has been obtained from the patient or the legally acceptable representative (However, if the Independent Ethics Committee/Institutional Review Board approves, including cases in which it is difficult to obtain consent from the patient or the legally acceptable representative due to death or other reasons, opt-out enrollment will be permitted.)
Key exclusion criteria
1.Received Tec or Tal treatment for MM as part of a clinical trial (for the Tec and Tal cohorts, respectively).
2.Received Tec or Tal treatment as bridging therapy for CAR-T (for the Tec and Tal cohorts, respectively)
3.Received Tec + Tal combination therapy
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Pauline |
| Middle name | |
| Last name | Ng |
Organization
Johnson & Johnson Innovative Medicine Janssen Pharmaceutical K.K.
Division name
Medical affairs
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo
TEL
03-4411-7700
tjinnai@its.jnj.com
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Jinnai |
Organization
Johnson & Johnson Innovative Medicine Janssen Pharmaceutical K.K.
Division name
Medical affairs
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo
TEL
03-4411-7700
Homepage URL
tjinnai@its.jnj.com
Sponsor or person
Institute
Johnson & Johnson Innovative Medicine Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson Innovative Medicine 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
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.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
独立行政法人国立病院機構 渋川医療センター
社会医療法人若弘会 若草第一病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070458
