Trial · NCT07887984
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients who are classified as being MRD-negative post-consolidation (Phase II) | Up to 1 year from registration | Will be defined as the number of patients who are identified as having no detectable minimal residual disease (MRD) (absence of malignant cells at a sensitivity threshold of 10\^-5 or lower using next generation sequencing) after consolidation therapy divided by the total number of evaluable patients on the given treatment arm. Will conduct separate pairwise comparisons of each of the three bispecific antibody (BsAb) treatment arms against the common control arm. |
| Primary | Progression-free survival (PFS) (Phase III) | From date of randomization to the date of documented disease progression and/or death due to any cause, whichever comes first, assessed up to 20 years | Will be evaluated and compared using a log-rank test to compare differences between those randomized to receive the most promising BsAb as consolidation (identified from the phase II portion of this trial) vs. those randomized to receive consolidation with high-dose melphalan/autologous stem cell transplant (ASCT). PFS distributions will be evaluated graphically using the methods of Kaplan and Meier, 4-year PFS rates with corresponding 95% confidence intervals will be estimated. |
| Secondary | Overall survival (OS) (Phase II) | From randomization to the time of death due to any cause, assessed up to 20 years | Kaplan-Meier methods will be used to estimate key aspects and characteristics of the survival distributions. 4 year estimates will be generated along with corresponding 95% confidence intervals. |
| Secondary | ate of conversion from MRD-positive to MRD-negative post-induction to post-consolidation in each treatment arm (Phase II) | Up to 12 months from randomization | Defined as the number of patients converted from MRD-positive after induction to MRD-negative after consolidation therapy divided by the number of patients MRD-positive patients after induction. |
| Secondary | Overall rate of MRD-negativity in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients who achieve MRD-negativity after the start of treatment divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of MRD-negativity after 2 years of maintenance in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients who achieve MRD-negativity after maintenance divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of grade 3+ adverse events in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients with a grade 3+ adverse event divided by the number of patients that received treatment. |
| Secondary | Rate of grade 3+ serious infection in each treatment arm (Phase II) | Within 1 year of starting consolidation | Defined as the number of patients with a grade 3+ infection (CTCAE) divided by the number of patients starting consolidation therapy. |
| Secondary | Progression-free survival (PFS) (Phase II) | From date of randomization to the date of documented disease progression and/or death due to any cause, whichever comes first, assessed up to 20 years | For each treatment arm, 4-year PFS rates with corresponding 95% confidence intervals will be estimated using the method of Kaplan-Meier |
| Secondary | Overall response rate in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients who achieve the best response divided by the number of randomized patients to that treatment arm |
| Secondary | Rate of grade 3+ serious infection in each treatment arm (Phase III) | Within 1 year of starting consolidation | Defined as the number of patients with a grade 3+ infection (CTCAE) divided by the number of patients starting consolidation therapy. |
| Secondary | Overall survival (OS) (Phase III) | From randomization to the time of death due to any cause, assessed up to 20 years | Kaplan-Meier methods will be used to estimate key aspects and characteristics of the survival distributions. 4 year estimates will be generated along with corresponding 95% confidence intervals. |
| Secondary | Rate of MRD-negative post-consolidation in each treatment arm (Phase II) | Up to 12 months from randomization | Defined as the number of patients MRD-negative after consolidation therapy divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline |
| Secondary | Overall rate of MRD-negativity in each treatment arm (Phase III) | Up to 3 years from randomization | Defined as the number of patients who achieve MRD-negativity after the start of treatment divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of MRD-negativity after 2 years of maintenance in each treatment arm (Phase III) | Up to 3 years from randomization | Defined as the number of patients who achieve MRD-negativity after maintenance divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of conversion from MRD-positive to MRD-negative post-induction to post-consolidation in each treatment arm (Phase III) | Up to 12 months from randomization | Defined as the number of patients converted from MRD-positive after induction to MRD-negative after consolidation therapy divided by the number of patients MRD-positive patients after induction. |
| Secondary | Rate of sustained MRD-negativity (Phase III) | Up to 3 years from randomization | Defined as the number of patients with at least 12 months of sustained MRD-negativity divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of grade 3+ adverse events in each treatment arm (Phase III) | Up to 3 years from randomization | Defined as the number of patients with a grade 3+ adverse event divided by the number of patients that received treatment. |
| Secondary | Overall response rate in each treatment arm (Phase III) | Up to 3 years from randomization | Defined as the number of patients who achieve the best response divided by the number of randomized patients to that treatment arm |
| Other | PFS by sex | Up to 20 years | Will provide estimates of PFS and the corresponding 95% confidence intervals (CIs) by sex. |
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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