Trial · NCT07045909
Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)
NCT07045909, Phase 2, Recruiting, PETHEMA Foundation
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST). Trials, record NCT07045909. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07045909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)
- NCT number
- NCT07045909
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- PETHEMA Foundation
- Conditions
- De Novo Multiple Myeloma, Anitocabtagene Autoleucel
- Interventions
- Daratumumab, Isatuximab, Bortezomib, Lenalidomide, Cyclophosphamide, Fludarabine, Anitocabtagene Autoleucel
- First posted
- 2025-07-01
- Last updated
- 2025-08-01
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of all adverse events (AEs) | 3 years | To characterize the safety of anitocabtagene autoleucel following induction therapy (incidence of treatment-emergent adverse events). |
| Primary | Undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10-5) at 12 months (+/- 3 months) after enrollment. | 12 months | To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry (NGF, with a sensitivity level of 10-6). |
| Secondary | Undetectable minimal residual disease (MRD) negative CR rate (minimum 10-5) at 2, 6, 12, 18 and 24 months after CAR T infusion and sustained undetectable minimal residual disease (uMRD) annually. | 2 years | To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry. |
| Secondary | Stringent complete response (sCR) or complete response (CR) rate, as assessed by investigators according to the International Myeloma Working Group (IMWG) criteria. | 6 months | CR measured by cytomorphplogy and flow cytometry. |
| Secondary | Overall MRD negativity (minimum 10e-5) | 3 years | MRD measured by Next Generation Flow Cytometry. |
| Secondary | Rate of conversion from undetectable to detectable MRD as well as biochemical progression rate. | 3 years | MRD measured by Next Generation Flow Cytometry. Biochemical progression by measuring serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms. |
| Secondary | Time to biochemical progression (including the conversion from undetectable to detectable MRD). | 3 years | MRD measured by Next Generation Flow Cytometry. Serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms. |
| Secondary | Undetectable MRD at 10e-6 (0.0001%) | 3 years | MRD measured by Next Generation Flow Cytometry. Undetectable MRD at 10e-6 (10 elevated to -6, which is the same as 0.0001%) means no presence of multiple myloma cells within 1,000,000 cells analyzed by flow cytometry |
| Secondary | Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) criteria | 3 years | ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, VGPR, or PR) per IMWG criteria. |
| Secondary | Duration of Response (DoR) | 3 years | DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per IMWG criteria and is defined as the time from first overall response to disease progression per IMWG criteria, or death from any cause, whichever occurs first. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07045909
GET https://conductscience.org/api/trials/v1/NCT07045909/registered