Trial · NCT03937635
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 | Overall survival (OS) | From randomization to death due to any cause, or censored at date last known alive, assessed up to 15 years | Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate. |
| Primary | Functional Assessment of Cancer Therapy-General (FACT-G) score | Baseline to 24 cycles of treatment (each cycle is 28 days) | A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, standard deviation \[SD\], median, range) will be used to evaluate the distribution of levels and changes for the set of health-related quality of life (QOL) evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck. |
| Secondary | Progression-free survival (PFS) | From randomization until disease progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 15 years | Will be estimated using the KM method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate. |
| Secondary | Best response on treatment based on International Myeloma Working Group (IMWG) criteria | At 12 and 24 months | Response will be tabulated by category. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will be compared using the Fisher's exact test. Ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator. |
| Secondary | Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Up to 28 days post-treatment | Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test. |
| Secondary | Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE | During cycle 1 of treatment (each cycle is 28 days) | Will monitor the toxicities experienced by all treated patients. Will compare rates of worst grade 3 or higher non-hematologic treatment-related events using the Fisher's exact test. |
| Secondary | Stem cell (SC) mobilization failure | After 4 to 6 cycles of treatment (each cycle is 28 days) | Defined as not collecting a minimum of 5x10\^6 CD34 cells per kilogram weight. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics. |
| Secondary | Early SC mobilization feasibility | Up to 6 cycles of treatment (each cycle is 28 days) | Defined as the proportion of patients less than 65 years of age treated for 6 courses who opt for SC mobilization. SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics. |
| Secondary | Type of growth factor support | During 4 to 6 cycles of treatment (each cycle is 28 days) | SC mobilization and type of growth factor support will be summarized overall and by treatment arm with descriptive statistics. |
| Secondary | Change in FACT-G score | From treatment end to 6 months post-treatment | A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck. |
| Secondary | Levels of FACT-G score at each assessment time point | From baseline, at 3, f7, 13, 19 cycles of treatment, and early discontinuation of treatment, assessed up to 24 cycles of treatment (each cycle is 28 days) | A general effect size measure of half standard deviation will be used to establish the minimally important difference. Descriptive statistics (mean, SD, median, range) will be used to evaluate the distribution of levels and changes for the set of health-related QOL evaluations. Levels and changes will also be assessed graphically. Changes from baseline will be analyzed using linear mixed models based on restricted maximum likelihood estimation with covariance matrix maximizing Akaike information criteria. Models with treatment, assessment time, and treatment by assessment time interaction with and without other predictors will be fit. If there is substantial missingness, will analyze the data according to the methods described in Schluchter and Schluchter, Greene and Beck. |
| Secondary | Time to worsening of FACT-G | From baseline until a decrease of 9 points, or censored at date of last assessment, assessed up to 6 months post-treatment | Will be analyzed with Kaplan-Meier methods and Cox regression with the related treatment arm as the only factor. Correlation between time to worsening of symptoms with PFS and OS will be assessed with Kendall's Tau adjusted for censored observations. |
| Other | Cumulative dose calculated as the sum of all doses taken across all cycles | Up to 24 months | Cumulative dose will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (\< 75% versus \[vs\] \>= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence. |
| Other | Dose intensity calculated as cumulative dose received divided by treatment duration | Up to 24 months | Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (\< 75% vs \>= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence. |
| Other | Relative dose intensity calculated as the dose intensity divided by planned dose intensity | Up to 24 months | Dose intensity will be calculated overall and by cycle. Data will be summarized by treatment arm with descriptive statistics and graphically over time. Patients will be classified into dichotomous groups based on a 75% relative dose intensity cutoff (\< 75% vs \>= 75% represents poor vs good treatment adherence). The proportion of patients with poor lenalidomide treatment adherence will be compared between arms using the Fisher's exact test. In addition, multi-variable logistic regression analysis will be conducted to identify the baseline factors associated with calculated good treatment adherence. |
| Other | Duration of treatment | From randomization to date off treatment, or censored at the date of last treatment, assessed up to 24 months | Treatment duration in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test. |
| Other | Time to progression | From randomization to progression, or censored at date of last disease evaluation, assessed up to 15 years | Will be estimated using the Kaplan-Meier method. |
| Other | Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs | Assessed at each treatment cycle, from cycle 1 of treatment to end of treatment, up to 24 cycles of treatment (each cycle is 28 days) | Descriptive statistics (mean, standard deviation, median, range) will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported adverse events (AEs) and evaluate differences in incidence and worst severity. Items correspond to 5 attributes measured \[frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)\] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. An overall PRO-CTCAE score will be calculated at each time point. |
| Other | Overall PRO-CTCAE score | Up to 15 years | Defined as the sum of item scores on all symptomatic adverse events (AEs). Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. Will map PRO-CTCAEs with provider reported AEs and evaluate differences in incidence and worst severity. An overall PRO-CTCAE score will be calculated at each time point. |
| Other | Adherence Starts with Knowledge (ASK)-12 scores | At 7, 13, and 19 cycles of treatment (each cycle is 28 days) | Descriptive statistics will be used to summarize ASK-12 scores tabulated at cycles 7, 13 and 19 overall and by arm. Differences between arms will be evaluated based a t-test (or Wilcoxon rank sum test). Patients will also be classified into high versus low likelihood of medication adherence groups according to tertile distributions (lowest tertile vs second and top). Association between likelihood of medication adherence and calculated treatment adherence dichotomous groups will be evaluated in patients with both ASK-12 and treatment data at cycles 7, 13 and 19 post randomization. In addition, multivariable logistic regression analysis will be conducted to identify the baseline factors associated with low likelihood of medication adherence. |
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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