Trial · NCT04756401
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Minimal Residual Disease (MRD) Negative Status | Up to 5 years post-treatment | MRD negative status at 10\^-5 level of sensitivity by flow cytometry will be considered synonymous with "success", unless specified otherwise. The proportion of success will be estimated by the number of success divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. |
| Secondary | Overall Response Rate (ORR) | 2 years | Will be estimated by the total number of patients who achieve a confirmed response at any time divided by the total number of evaluable patients. A confirmed response is defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) noted as the objective status on two consecutive evaluations at least two weeks apart. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. The depth of response (PR versus VGPR versus CR versus sCR) will also be summarized. |
| Secondary | Time to Response | 2 years | Time to response (TTR) is defined as time from the date of registration to the date of confirmed response using IMWG criteria. TTR will be summarized descriptively (median, range). |
| Secondary | Duration of Response | 2 years | Duration of response (DOR) is defined as time from date at which the patient's confirmed objective status is noted to the earliest date of progression or death. The DOR will be estimated using the method of Kaplan-Meier. |
| Secondary | Progression-free Survival | 2 years | The progression free survival (PFS) is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of PFS will be estimated using method of Kaplan-Meier. |
| Secondary | Overall Survival (OS) | 2 years | The overall survival (OS) is defined as the time from registration to death due to any cause. The distribution of OS will be estimated using method of Kaplan-Meier. |
| Secondary | MRD Negativity Rate at 10^-6 of Sensitivity | 2 years | Will be assessed in the bone marrow by flow cytometry estimated as the number of patients who have achieved MRD negative result at 10\^-6 level of sensitivity at any time divided by the total number of evaluable patients. Exact 95% binomial confidence intervals for the true rate of MRD negative response will also be calculated. |
| Secondary | Number of Patients With a Grade 3 or Greater Adverse Event | 2 years | Will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number of patients with at least one grade 3 or greater AE, regardless of attribution, will be reported. |
| Other | Effect of Immunomodulatory Imide Drug-14 Scores Gene Expression Profile (GEP) on Progression-Free Survival | Baseline up to progression-free survival, assessed up to 5 years | The progression free survival (PFS) is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients will be categorized by their GEP and progression-free survival estimates will be compared across GEP scores. |
| Other | Change in EORTC QLQ-C30 Scores From Baseline to End of Treatment | Baseline up to progression, withdrawal, or end of treatment, assessed up to 5 years | QOL will be measured using the EORTC QLQ-C30, a patient-reported questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. Changes in raw score from baseline to end of treatment will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported. |
| Other | Change in EORTC QLQ-MY20 Scores From Baseline to End of Treatment | Baseline up to progression, withdrawal, or end of treatment, assessed up to 5 years | QOL will be measured using the QLQ-MY20, a patient-reported questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. Changes in raw score from baseline to end of treatment will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported. |
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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