Trial · NCT05572229
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 | Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len | At the end of 4 th cycle (each cycle is 28 days), an average 4 months | |
| Secondary | Treatment-emergent adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0). | From date of randomization until the date of first documented progression,assessed up to 5 years | |
| Secondary | Overall response rate(PR or better) as defined by the IMWG response criteria | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Very good partial response or better, defined as VGPR or CR according to the IMWG criteria at the time of data cutoff | TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Complete response or better, defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow* | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Time to response | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Duration of response | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Time from randomization to discontinuation of therapy for any reason including death, progression or toxicity | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Overall survival time | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | OS, measured from the date of the first dose of study treatment to the date of the patient's death. If the patient is alive or the vital status is unknown at last contact, then the patient's data will be censored at the date the patient was last known to be alive |
| Secondary | TTTF, defined as the time from the date of the first dose of study treatment to discontinuation of therapy for any reason including death, progression, toxicity | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | TTNT, defined as the time from date of the first dose of study treatment to the start of the next-line treatmentTime-to-next treatment | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Rate of minimal residual disease (MRD)-negativity (at level of 10-5 and 10-6 by NGS) at 6 months | at 6 months | |
| Secondary | Rate of Sustained MRD-negativity-(at level of 10-5 and 10-6 by NGS) | at 18 months (12 months after the initial MRD time point). |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05572229/registered