Elranatamab With Mezigdomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Trial · NCT07901868
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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. |
| Secondary | To evaluate the Overall Survival with Elranatamab in combination with mezigdomide and dexamethasone. | 5 years | Defined as the time from the date of Elranatamab treatment initiation until the date of death due to any cause. |
| Secondary | Incidence of Adverse Events (AE) related with the treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Number of adverse events registered within the clinical trial study period related with the treatment with elranatamab in combination with mezigdomide and dexamethasone. Adverse Events are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure, and are evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Secondary | Discontinuation of therapy due to Adverse Event related with the treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Defined as the percentage of patients discontinuing therapy due to Adverse Events of treatment with elranatamab in combination with mezigdomide and dexamethasone |
| Secondary | Dose modifications due to Adverse Events related with treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Defined as the percentage of patients requiring dose modifications due to Adverse Events of treatment with elranatamab in combination with mezigdomide and dexamethasone |
| Secondary | Incidence of Severe Adverse Events of treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Number of severe adverse events, defined as: Any untoward medical occurrence that, at any dose; * Results in death; * Is life threatening; * Requires inpatient hospitalization\* or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly/birth defect; * Is an important medical event; * Is associated with liver injury and impaired liver function defined as: ALT ≥3 x ULN and total bilirubina ≥2 x ULN (\>35% direct), or ALT ≥3 x ULN and INRb \>1.5. * Any suspected transmission of any infectious agent via a product (medically significant) |
| Secondary | Changes in laboratory analytes from the hematology and blood chemistry panel related to treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Defined as the number of the changes in laboratory analytes from the hematology and blood chemistry panel related to treatment with elranatamab in combination with mezigdomide and dexamethasone |
| Secondary | Incidence of deaths related with the treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Defined as the number of deaths related with the treatment with elranatamab in combination with mezigdomide and dexamethasone |
| Secondary | Primary cause of death of treatment with elranatamab in combination with mezigdomide and dexamethasone | 5 years | Defined as the description of the cause of death related with the treatment with elranatamab in combination with mezigdomide and dexamethasone |
| Other | To assess the immune profile induced by elranatamab alone, the triplet combination, and treatment with mezigdomide plus dexamethasone | 5 years | Immune profiling (qualitative and quantitative study of the composition of B and T leukocytes) performed by Next Generation Flow Cytometry in peripheral blood, during treatment with: * Elranatamab + Dexamethasone * Elranatamab cycles 2 and 3 + Mezigdomide + Dexamethasone * Elranatamab from cycle 4 onwards + mezigdomide + Dexamethasone * Elranatamab from cycle 4 onwards + Mezigdomide * Mezigdomide maintenance |
| Other | To assess Progression-free survival according to the quality of the response. | 5 years | Estimated Progression-free survival according to achievement of MRD negativity (yes/no). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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