Trial · NCT06918002
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 | Part 1 (induction/consolidation) from Randomization 1 (R1): to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Minimal Residual Disease (MRD) negativity rate | at end of consolidation, up to 36 months | To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of MRD negativity rate. |
| Primary | Part 2 (maintenance) from Randomization 2 (R2): to assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of Progression Free Survival (PFS). | from the date of second randomization to the date of confirmed PD (IMWG criteria,) or death from any cause, whichever came first, assessed up to 93 monts | To assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of PFS. |
| Primary | Key secondary objectives: Part 1 (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS | PFS defined as the time interval from the date of first randomization to the date of confirmed Progression Disease (IMWG criteria) or death from any cause, whichever occurs first., assessed up to 128 months | To assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS |
| Primary | Key secondary objectives: Part I (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Overal Survival (OS) | up to 128 months | To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of OS |
| Secondary | Part 1 (induction/consolidation) from R1: to assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care | End of consolidation phase, up to 36 months | To assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care: Overall response rate (ORR), Very good partial response (VGPR) rate, Complete response (CR) rate |
| Secondary | Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab | end of maintenance, up to 58 months | To assess the efficacy of maintenance therapy with elranatamab: * Overall response rate (ORR) in maintenance * Very good partial response (VGPR) rate in maintenance * Complete response (CR) rate in maintenance |
| Secondary | assess safety & Tolerability during induction, and during consolidation and maintenance therapy: Adverse events (AE), serious Adrverse events (SAE) and And adverse events of special interest (AESI) rates - Incidence of Treatment-Emergent Adverse Events | through study completion, up to 128 months | To assess safety during induction, and during consolidation and maintenance therapy: AEs, SAE and AESI rates , Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
| Secondary | Throughout the study to evaluate the impact of treatment on health-related Quality of Life (QoL) using Rework questionnaire | through study completion, up to 128 months | To evaluate the impact of treatment on health-related QoL: Rework questionnaire |
| Secondary | Part 2 (maintenance) from Randomization 2 (R2): to assess the efficacy of maintenance therapy with elranatamab, Progression Free Survival 2 form Randomization 2 | up to 128 months | To assess the efficacy of maintenance therapy with elranatamab: \- PFS of subsequent/next treatment line (PFS2 from R2) |
| Secondary | Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab, in term of Minimal Residual Disease negativity | 12 months post R2, up to 71 months | To assess the efficacy of maintenance therapy with elranatamab: \- MRD negativity at 12 months post R2 |
| Secondary | Throughout the study: to evaluate the impact of treatment on health-related Quality of Life (QoL) using EQ-5D-5L | Though study completion, an average of 11 years | To evaluate the impact of treatment on health-related QoL: scale title :EQ-5D-5L , the minimum value is 0 and maximum value is 100 (100 corresponds to the best health that patient can imagine, 0 corresponds to the worst health that patient can imagine |
| Secondary | Part 2 (maintenance) from R2: To assess the efficacy of maintenance therapy with elranatamab (OS R2) | up to 128 months | To assess the efficacy of maintenance therapy with elranatamab: \- Overall survival from second randomization (OS R2) |
| Other | EXPLORATORY OBJECTIVES: to assess the impact of genomic markers (from Next generation sequencing (NGS) and Whole Genome Sequencing (WGS)) on outcome | up to 128 months | To assess the impact of genomic markers (from NGS and WGS) on outcome: MRD negativity rate as determined by NGS with a sensitivity of at least 10-5 - PFS1 and OS |
| Other | EXPLORATORY OBJECTIVES: to assess Immune mechanisms predicting Elra-Len vs ASCT efficacy | up to 128 months | Impact of the microenvironment (Immune mechanisms predicting Elra-Len vs ASCT efficacy) according to outcome (MRD, PFS and OS) rates |
| Other | EXPLORATORY OBJECTIVES: to assess the impact of PET imaging parameters/variables on outcome | End of consolidation phase, up to 36 months | rate of PET imaging positive / negative according to outcome (MRD, PFS and OS) rates |
| Other | EXPLORATORY OBJECTIVES: To determine influence of M-component measurement assessed by mass spectrometry on outcome | up to 128 months | To determine influence of M-component measurement assessed by mass spectrometry on outcome |
| Other | EXPLORATORY OBJECTIVES: To determine influence of circulating tumor cells on outcome in term of PFS1 and OS | up to 128 months | To determine influence of circulating tumor cells on outcome in term of PFS1 and OS |
| Other | Exploratory objective :To evaluate the pharmacokinetics (PK) of elranatamab | up to 128 months | Predose and postdose concentrations of elranatamab |
| Other | Exploratory objective : To evaluate the immunogenicity of elranatamab | up to 128 months | To evaluate the immunogenicity of elranatamab |
| Other | Exploratory objective :To explore correlations between elranatamab exposure and efficacy, safety and biomarker endpoints, if data allow | up to 128 months | To explore correlations between elranatamab exposure and efficacy, safety and biomarker endpoints, if data allow |
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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GET https://conductscience.org/api/trials/v1/NCT06918002/registered