Trial · NCT07110844
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematologic Complete Response (Heme-CR) rate | 6 months from treatment initiation | Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response. |
| Secondary | Minimal Residual Disease (MRD) negativity rate by Free Light Chain Mass Spectrometry (FLC-MS) in serum | 1 month, 3 months, 6 months, and 18 months | Secondary outcome is to assess the rate of minimal residual disease (MRD)-negativity and sustained MRD-negativity with Teclistamab-Daratumumab |
| Secondary | MRD-negativity rate by multiparameter flow cytometry (MFC) in bone marrow | 6 months and 18 months | The MRD-negativity rate by 6 and 18 months will be reported descriptively. |
| Secondary | Time to heme-CR | Day 1 of each cycle, and every 6 weeks after treatment cessation (up to 1 year) | Time to heme-CR will be calculated from the day of treatment initiation (C1D0), and will be reported as median (range). |
| Secondary | Major organ deterioration-progression-free survival (MOD-PFS) rate | From Cycle 2 to Cycle 6 Day 1 (Each cycle is 28 days), End of treatment visit (up to 6 months from treatment initiation), and up to 18 months from treatment initiation | MOD-PFS will be calculated as a time-to-event endpoint using Kaplan-Meier method. |
| Secondary | Overall survival rate | Through study completion, up to 18 months from treatment initiation | Overall survival frequency from initiation of study drug, including cause of death for patients who die on study |
| Secondary | Frequency of Cytokine Release Syndrome (CRS) | Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months) | Frequency of CRS (all-grade and grade ≥3) events |
| Secondary | Rate of infections | Throughout Cycle 1 (each cycle is 28 days), Day 0, Day 1, Day 3, Day 8, Day 15, Day 22; Throughout Cycle 2 and Cycle 6 on Day 1 and Day 15; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months) | Frequency rate of infections (all-grade and grade ≥3) will be reported descriptively. |
| Secondary | Number of participants with a heart response after treatment | 6 months and 18 months | Heart response is defined as N-terminal pro Brain Natriuretic Peptide (NT-ProBNP) response (\>30% and \>300 ng/l decrease in subjects with baseline NT-proBNP\>650 ng/l) or New York Heart Association (NYHA) class response (\>2 class decrease in subjects with baseline NYHA class 3 or 4) |
| Secondary | Number of No Responses in the heart after treatment | 6 months and 18 months | No response in the heart is defined as ≤30% reduction in NT-proBNP from baseline |
| Secondary | Number of Partial Responses (PR) in participants who experienced a heart response after treatment | 6 months and 18 months | Partial Response in the heart is defined as 31-60% reduction in NT-proBNP from baseline. |
| Secondary | Number of Very Good Partial Responses (VGPR) in participants who experienced a heart response after treatment | 6 months and 18 months | VGPR in the heart is defined as \>60% reduction in NT-proBNP from baseline to a nadir of \>350 ng/L |
| Secondary | Number of Complete Response (CR) in participants who experienced a heart response after treatment | 6 months and 18 months | Complete Response in the heart is defined as Nadir NT-proBNP≤350 ng/L |
| Secondary | Number of participants with heart progression after treatment | 6 months and 18 months | Heart progression is defined as NT-proBNP progression (\>30% and \>300 ng/l increase) or cardiac troponin progression (\>33% increase) or ejection fraction progression (\>10% decrease). Subjects with progressive worsening renal function cannot be scored for NT-proBNP progression. |
| Secondary | Number of participants with a kidney response after treatment | 6 months and 18 months | Kidney response is defined as 50% decrease (at least 0.5 g/day) of 24-h urine protein (urine protein must be \>0.5g/day pretreatment). Creatinine and creatinine clearance must not worsen by 25% over baseline. |
| Secondary | Number of No Responses in the kidneys after treatment | 6 months and 18 months | No response in the kidneys is defined as ≤30% reduction in proteinuria from baseline |
| Secondary | Number of Partial Responses (PR) in participants who experienced a kidney response after treatment | 6 months and 18 months | Partial Response in the kidneys is defined as 31-60% reduction in proteinuria from baseline |
| Secondary | Number of Very Good Partial Responses (VGPR) in participants who experienced a kidney response after treatment | 6 months and 18 months | VGPR in the kidneys is defined as \>60% reduction in proteinuria from baseline level to a nadir level \>200 mg/24 hours |
| Secondary | Number of Complete Response (CR) in participants who experienced a kidney response after treatment | 6 months and 18 months | Complete Response in the kidneys is defined as Nadir proteinuria ≤200 mg/24 hours |
| Secondary | Number of participants with kidney progression after treatment | 6 months and 18 months | Kidney progression is defined as 50% increase (at least 1 g/day) of 24-h urine protein to \>1 g/day or 25% worsening of serum creatinine or creatinine clearance. |
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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