Trial · NCT02513498
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | Up to 30 days following completion of study treatment | According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 |
| Primary | Probability of Treatment Failure at 6 Months | 6 months | Kaplan-Meier estimate assessed at 6 months for probability of treatment failure, defined as addition of a line of systemic immune-suppressive therapy, recurrent malignancy, or death. |
| Secondary | Biologic Studies | Up to 6 months | The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed. |
| Secondary | Complete Response (CR) Rate | 6 months | Response will be determined by both clinician-defined, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference. |
| Secondary | Probability of Non-relapse Mortality at 1 Year | 1 year | Kaplan-Meier estimate assessed at 1 year for probability of non-relapse mortality, defined as death in the absence of primary malignancy relapse after transplant. |
| Secondary | Cumulative Incidence of Primary Malignancy Relapse | 1 year | Defined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation. |
| Secondary | Probability of Failure-free Survival at 1 Year | 1 year | Kaplan-Meier estimate assessed at 1 year for failure-free survival, defined as the absence of death from any cause, relapse or addition of secondary immune suppressive agents. |
| Secondary | Incidence of Discontinuation of All Systemic Immune Suppressive Therapies | 1 year | The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year. |
| Secondary | Overall Response Rate (ORR) (Complete Response + Partial Response) | 6 months | ORR at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference. |
| Secondary | Probability of Overall Survival at 1 Year | 1 year | Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause. |
| Secondary | Treatment Success | 1 year | Treatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic graft-versus-host disease (GVHD) manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant. |
| Secondary | Use of Additional Systemic Immune Suppressive Therapies | 1 year | Addition of therapy after ixazomib constitutes failure, could occur at any time from baseline to 12mo. |
| Secondary | Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36) | 1 year | SF-36 subscales have min=0 and max=100; results given are actual scores at 12mo, with higher scores indicating higher quality of life. |
| Secondary | Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT) | 1 year | FACT-BMT subscales have various min/max, see below; results given are actual 12mo scores, with higher scores indicating better functioning. FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148) |
| Secondary | Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP) | 1 year | HAP subscales have min=0 and max=94; results given are actual 12mo scores, with higher scores indicating better functioning. Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs. Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities. Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78. |
| Secondary | Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale | 1 year | Lee symptom scale (LSS) has subscales with min=0, max=100; results given are 12mo scores, with higher numbers indicating higher symptom burden. |
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.
For software
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