Multiple MyelomaNCT05161598
Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
A study testing Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC.
Trial summary
Teclistamab pre-approval access in relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Teclistamab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors [PIs], immunomodulatory imide drugs [IMIDs], anti CD38 monoclonal antibodies [mAbs] and therapies targeting Exportin 1 [XPO1] and B cell maturation antigen [BCMA]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting
About this study
Official title: PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use
Teclistamab pre-approval access in relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Teclistamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called JNJ-64007957
Teclistamab will be administered subcutaneously (SC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161598
- Sponsor's protocol ID
- CR108846
- Other IDs
- 64007957PTL4001
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2021
- Last updated
- 16 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use
- ClinicalTrials.gov ID
- NCT05161598
- Acronym / sponsor ID
- CR108846
- Conditions
- Multiple Myeloma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Teclistamab pre-approval access in relapsed or refractory multiple myeloma.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: JNJ-64007957Teclistamab will be administered subcutaneously (SC). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.