Multiple MyelomaBISPEMMNCT06359067
A Real-World Study of Bispecific Antibodies in Multiple Myeloma
An observational study of Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with multiple myeloma treated with bispecific antibodies, teclistamab or elranatamab.
Who may be able to join
- Adult ≥ 18 years old
- Patients with multiple myeloma
- Patients who received at least one administration of the following therapies: teclistamab, elranatamab
Who cannot join
- Patients opposed to the collection of their personal data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Study of Bispecific Antibodies, Teclistamab and Elranatamab, for Patients With Multiple Myeloma
Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).
Read the detailed description
Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).
- Conditions
- Multiple Myeloma
- Being tested
- Treated by bispecific antibodies, teclistamab or elranatamab in usual care, Not treated by bispecific antibodies in usual care
- Keywords
- Multiple myeloma, Teclistamab, Elranatamab, Bispecific antibody
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treated by bispecific antibodies, teclistamab or elranatamab in usual careOther
Treated by bispecific antibodies, teclistamab or elranatamab in usual care
Not treated by bispecific antibodies in usual careOther
Not treated by bispecific antibodies in usual care
| Study group | Role | What they receive |
|---|---|---|
| Treated by bispecific antibodies | Patients with multiple myeloma, penta-drug or triple class refractory and treated by bispecific antibodies, teclistamab or elranatamab Receives: Other: Treated by bispecific antibodies, teclistamab or elranatamab in usual care | |
| Control group | Patients with multiple myeloma, penta-drug or triple class refractory and not treated by bispecific antibodies Receives: Other: Not treated by bispecific antibodies in usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate
Explore the infection rate
Measured: Up to 18 months
Secondary outcomes (2)
Global survival
Explore the global survival
Measured: Up to 18 months
Progression-free survivals
Explore the progression-free survivals
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremie ZERBIT, PharmD, Principal investigator, Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359067
- Sponsor's protocol ID
- APHP240295
- Acronym
- BISPEMM
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Bispecific Antibodies, Teclistamab and Elranatamab, for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06359067
- Acronym / sponsor ID
- BISPEMM / APHP240295
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Teclistamab, Elranatamab, Bispecific antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Apr 2024 (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.
Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).
Detailed description
Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated by bispecific antibodies | – | Other: Treated by bispecific antibodies, teclistamab or elranatamab in usual carePatients with multiple myeloma, penta-drug or triple class refractory and treated by bispecific antibodies, teclistamab or elranatamab |
| Control group | – | Other: Not treated by bispecific antibodies in usual carePatients with multiple myeloma, penta-drug or triple class refractory and not treated by bispecific antibodies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with multiple myeloma treated with bispecific antibodies, teclistamab or elranatamab.
Key inclusion criteria (3 listed)
- Adult ≥ 18 years old
- Patients with multiple myeloma
- Patients who received at least one administration of the following therapies: teclistamab, elranatamab
Key exclusion criteria (1 listed)
- Patients opposed to the collection of their personal data
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 |
|---|---|---|
| Treated by bispecific antibodies, teclistamab or elranatamab in usual careTreated by bispecific antibodies, teclistamab or elranatamab in usual care | Other | Treated by bispecific antibodies |
| Not treated by bispecific antibodies in usual careNot treated by bispecific antibodies in usual care | Other | Control group |
Primary outcome
Infection rate
Time frame: Up to 18 months
Explore the infection rate
2 secondary outcomes
Global survival
Time frame: Up to 18 months
Progression-free survivals
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Jeremie ZERBIT, PharmD principal investigator
Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Infection rate (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
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 11 Apr 2024.