Trial · NCT04131309
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 | Overall Survival | 6 months | percentage of participants |
| Secondary | Overall Response Rate (ORR) | Overall (up to 9 months), 3 and 6 months | Best hematologic response rates, per International Amyloidosis Consensus Criteria: CR Normalization of free light chain ratio, negative serum and urine immunofixation; VGPR with baseline dFLC ≥ 50 mg/L, reduction in the dFLC to \<40 mg/L; PR b. baseline dFLC ≥ 50 mg/L, reduction in dFLC by ≥ 50% c. A greater than 50% reduction in M protein concentration, baseline dFLC is \<50 mg/L, M protein (≥5 g/L) d. baseline dFLC ≥ 20 and \< 50 mg/dL: dFLC \< 10 mg/dL; No response, Less than a PR; |
| Secondary | Major Organ Deterioration Progression-Free Survival (MOD-PFS). | Overall up to death or major organ deterioration | Major Organ Deterioration Progression-Free Survival (MOD-PFS) is a composite endpoint of clinically observable endpoints and will be defined from the start of study treatment (Cycle 1 Day 1) to any one of the following events (whichever occurs first) • Death or Major organ deterioration |
| Secondary | Progression Free Survival | Overall up to 2 years | documentation of hematologic disease progression, or organ (cardiac, renal, or liver) progression/need for transplant, or need for additional therapy (excluding the addition of bortezomib under protocol) or death due to any cause, whichever occurs first according to central laboratory results and judged by international consensus guidelines |
| Secondary | Time to Hematologic Response | overall up to 2 years | to evaluate the time to hematologic response |
| Secondary | Proportion of Additional Treatment | every 28 days, from start of study treatment (cycle 1 Day1) until end of treatment with a maximum of 2 years, average of 6 months | The proportion of subjects who received additional treatment with bortezomib and low dose dexamethasone (at the investigator's discretion). |
| Secondary | Organ Response Rate (OrRR) Heart | at 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (maximum of 2 years) | the organ response rate for the heart |
| Secondary | EORTC QLQ-C30 Scores Will be Summarized at Each Time Point. | Score changes from baseline to 4 months | The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology. |
| Secondary | Organ Response Rate (OrRR) Kidney | from registration to the date of disease progression or death with a maximum of 2 years | the organ response rate for kidney involvement |
| Secondary | Organ Response Rate (OrRR) Liver | from registration to the date of disease progression or death with a maximum of 2 years | the organ response rate for liver involvement |
| Secondary | EORTC QLQ-C30 Scores to End of Treatment | Score changes from baseline to end of treatment (EOT) | The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology. |
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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