Trial · NCT05066607
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematologic Response | At the end of Cycle 6 (each cycle is 28 days) | To assess hematologic response (VGPR or better i.e. dFLC \< 40 mg/L, CR including modified CR\*, low-dFLC response (dFLC \< 10 mg/L), iFLC \< 10 mg/l) achieved after 6 cycles of Isa-Pd. \*: If iFLC \<ULN and serum and urine immunofixation are negative, then neither a normal uFLC level nor a normal FLC ratio are required for complete response (CR). |
| Secondary | Overall Hematologic Response Rate | At the completion of the 1st, 2nd, 4th, 6th, 9th and 12th cycles (each cycle is 28 days) | To assess in all patients according to their disease history Overall Hematologic Response Rate (VGPR, CR, modified CR\*, Low-dFLC response (dFLC \< 10 mg/L), iFLC \< 10 mg/l and PR) at the completion of the 1st, 2nd, 4th, 6th, 9th and 12th cycles. \*: If iFLC \<ULN and serum and urine immunofixation are negative, then neither a normal uFLC level nor a normal FLC ratio are required for complete response (CR). |
| Secondary | Efficacy Measurement: Progression-free survival (PFS) | During the intervention and at 1 year | Time from the inclusion to either progressive disease or death |
| Secondary | Efficacy Measurement: relapse-free survival (RFS) | During the intervention | To evaluate the relapse-free survival (RFS) |
| Secondary | Efficacy Measurement: Organ response rate (OrRR) | 1 year | To evaluate the Organ response rate at 1 year |
| Secondary | Efficacy Measurement: Overall Survival (OS) | Though study completion, an average of 33 months | Time from initial inclusion to death |
| Secondary | Time to and the duration of haematologic and organ responses | During the intervention | To evaluate the time to and the duration of haematologic and organ responses |
| Secondary | Safety analysis | Until 30 days post last dose of protocol treatment | Rate of adverse events that occured during treatment period |
| Secondary | Cytogenetic: incidence of genetic translocation t(11;14) and impact on hematologic and organ response | Though study completion, an average of 33 months | To assess the impact of t(11.14) determined by Fluorescence In Situ Hybridation (FISH) at inclusion on treatment response. |
| Secondary | Cardiac function | After 6 cycles of IsaPd and at 1 year from start of therapy or 12 cycles of IsaPd (each cycle is 28 days). | To assess the concentration of NT-proBNP level and evaluate the impact of the NT-proBNP level on the strain change. |
| Secondary | Renal function | After 6 cycles of IsaPd and at 1 year from start of therapy or 12 cycles of IsaPd (each cycle is 28 days) | To assess albumin level to proteinuria/eGFR. |
| Secondary | Quality of Life : European Quality of Life 5 dimensions (EQ-5D-3L) | up to 15 months | patient reported outcome to assess health status in patients. The EQ-5D (European Quality of Life 3 dimensions) measures a wide range of health conditions and treatments; it is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale that records the patient's self-rated overall health state. Respondents rate each of these 5 dimensions from "no problem", "some problem" or "extreme problem". The EQ-VAS records the respondents' self-related health on a vertical, visual analogue scale. The range for EQ-VAS is from 0 (the worst health you can imagine) to 100 (=the best healt you can imagine). |
| Other | Minimal Residual Disease (MRD) | At the completion of 6 cycles of therapy or at 1 year from start of therapy (each cycle is 28 days) | To assess Minimal Residual Disease (MRD) by NGS in bone marrow and blood at the completion of 6 cycles of therapy or at 1 year from start of therapy for patients in CR/modified CR\* or low dFLC or normal iFLC (iFLC\< 10 mg/L) and by Mass Spectrometry in the blood. \*: If iFLC \<ULN and serum and urine immunofixation are negative, then neither a normal uFLC level nor a normal FLC ratio are required for complete response (CR). |
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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