Trial · NCT05695508
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
NCT05695508, Phase 2, Recruiting, University of Heidelberg Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5. Trials, record NCT05695508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05695508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
- NCT number
- NCT05695508
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 160 participants, estimated
- Lead sponsor
- University of Heidelberg Medical Center
- Conditions
- Multiple Myeloma
- Interventions
- Teclistamab (Tec), Daratumumab, Dexamethasone, Lenalidomide, Bortezomib, Talquetamab, JNJ-79635322
- First posted
- 2023-01-25
- Last updated
- 2025-12-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | number of incidence and severity of adverse events [safety and tolerability] | through study completion, up to 28 months | |
| Secondary | MRD negativity rate | after 6 cycles (each cycle is 28 days) induction therapy (app.month 6), after High Dose Therapy (app. month 10), after 18 cycles (each cycle is 28 days) of maintenance therapy (app. month 28) | MRD negativity rate measured by Flow Cytometry |
| Secondary | Response on therapy [efficacy] | after each cycle (each cycle is 28 days) induction ( app. at month 1,2,...,6), after High Dose therapy (app. month 10), after each cycle (each cycle is 28 days) of maintenance (app. at month 11,12, ...28), during FU every 3 months (app. up to 3-4 years) | Response on therapy according to IMWG: * Overall Response Rate (ORR) (at least a PR or better) * Complete Response (CR) or better * Very Good Partial Response (VGPR) or better * Duration of Response (DoR) |
| Secondary | Progression Free Survival [efficacy] | From randomization to the date of disease progression to death (app. up to 3-4 years) | |
| Secondary | Serum concentration of teclistamab, talquetamab and daratumumab [pharmacokinetics] | through study completion, up to 28 months | |
| Secondary | Presence of ADAs to teclistamab, talquetamab and daratumumab [immunogenicity] | through study completion, up to 28 months | |
| Secondary | Stem cell yield | after High Dose Therapy (after app. 10 months) | feasibility of successful transplantation |
| Secondary | days to engraftment | after High Dose Therapy (after app. 10 months) | feasibility of successful transplantation |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42350642 | DERIVED |
Source PubMed
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/NCT05695508
GET https://conductscience.org/api/trials/v1/NCT05695508/registered