Trial · NCT07901868
Elranatamab With Mezigdomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
NCT07901868, Phase 2, Not yet recruiting, PETHEMA Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Elranatamab With Mezigdomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma. Trials, record NCT07901868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Elranatamab With Mezigdomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT07901868
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- PETHEMA Foundation
- Conditions
- Multiple Myeloma Refractory, Multiple Myeloma in Relapse
- Interventions
- Dexamethasone, Mezigdomide, Elranatamab
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients achieving minimal residual disease (MRD) negativity. | 5 years | To evaluate the percentage of participants achieving negative MRD. Negative MRD is defined as the presence of less than 1 tumour cell among 100,000 healthy hematopoietic cells by Next Generation Flow Cytometry in bone marrow, according to the IMWG criteria. |
| Secondary | Proportion of participants showing sustained MRD negativity at 24 months | 5 years | Percentage of participants showing sustained MRD negativity at 24. Negative MRD is defined as the presence of less than 1 tumour cell among 100,000 healthy hematopoietic cells by Next Generation Flow Cytometry in bone marrow, according to the IMWG criteria. |
| Secondary | Proportion of participants showing MRD negativity after early rescue intervention with elranatamab in patients on mezigdomide alone after C12. | 5 years | Those participants showing good initial treatment response (allocated in the MRD negative at end cycle 12 intervention arm and receiving Mezigdomide maintenance therapy) who show MRD positivization during maintenance therapy with Mezigdomide alone, will be evaluated to detect the rate of MRD negativization after early rescue intervention with Elranatamab. Negative MRD is defined as the presence of less than 1 tumour cell among 100,000 healthy hematopoietic cells by Next Generation Flow Cytometry in bone marrow, according to the IMWG criteria. |
| Secondary | To evaluate the Complete Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria. | 5 years | Defined as the percentage of patients who show the following 4 parameters: i) absence of monoclonal protein in serum, ii) absence of monoclonal protein in urine, iii) disappearance of any previous soft tissue plasmacytomas, iv) less than 5% plasma cells in bone marrow aspirates or biopsy |
| Secondary | To evaluate the Very Good Partial Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria. | 5 years | Defined as having the following conditions: i) \>90% reduction of M protein in serum, ii) less than 100 mg of M protein un urine within 24 hours, iiI) no presence of plasmocitomas. |
| Secondary | To evaluate the Partial Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria. | 5 years | Defined as havong the following: i) \>50% reduction of serum M protein, ii) \<200mg of M-protein in urine in 24-hour. |
| Secondary | To evaluate the Minimal Response rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria. | 5 years | Defined as showing a 25% to 49% reduction in serum monoclonal M-protein alongside a 50% to 89% reduction in 24-hour urinary M-protein. |
| Secondary | To evaluate the Stable Disease rate to elranatamab in combination with mezigdomide and dexamethasone, based on confirmed response according to the IMWG criteria. | 5 years | Defined as \>25% reduction in serum monoclonal M-protein alongside a \>50% reduction in 24-hour urine M-protein. |
| Secondary | To evaluate the Duration of Response with Elranatamab in combination with mezigdomide and dexamethasone. | 5 years | Defined as the time from the achievement of at least a Partial Response until the earliest date of documented disease progression by IMWG criteria. |
| Secondary | To evaluate the Progression-free Survival with Elranatamab in combination with mezigdomide and dexamethasone. | 5 years | Defined as the time from the date of Elranatamab treatment initiation until the earliest date of documented disease progression by IMWG criteria or death due to any cause. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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/NCT07901868
GET https://conductscience.org/api/trials/v1/NCT07901868/registered?page=2