Trial · NCT06215118
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 | Part 1: Number of participants with dose limiting toxicity (DLT) | Cycle 1, about 28 days | Dose limiting toxicity rate based on dose limiting toxicity evaluable participants |
| Primary | Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment | Assessed from baseline up to 90 days after last dose of study treatment | Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator. |
| Secondary | Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment | Assessed from baseline up to 90 days after last dose of study treatment | Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator. |
| Secondary | Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity | Assessed from baseline up to 90 days after last dose of study treatment | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship |
| Secondary | Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities | Assessed from baseline up to 90 days after last dose of study treatment | Laboratory abnormalities as characterized by type, frequency, severity |
| Secondary | Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR) | Assessed for approximately 2 years | Percent of participants having confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) per IMWG criteria as determined by investigator |
| Secondary | Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR) | Assessed for approximately 2 years | Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator |
| Secondary | Part 1 and Part 2: Time to Response (TTR) | Assessed for approximately 2 years | For participants with an objective response per IMWG criteria, TTR is the time from first dose to the first documentation of objective response that is subsequently confirmed |
| Secondary | Part 1 and Part 2: Duration of Response (DOR) | Assessed for approximately 2 years | For participants with an objective response per IMWG criteria, DOR is the time from first documentation of objective response that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria |
| Secondary | Part 1 and Part 2: Duration of Complete Response (DOCR) | Assessed for approximately 2 years | For participants with a Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria, DOCR is the time from the first documentation of CR/sCR that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria |
| Secondary | Part 1 and Part 2: Time of Progression Free Survival (PFS) | Assessed for approximately 2 years | Progression free survival (IMWG criteria) |
| Secondary | Part 1 and Part 2: Time of Overall Survival (OS) | Assessed for approximately 2 years | The duration of time from first dose of study treatment to death |
| Secondary | Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate | Assessed for approximately 2 years | The proportion of participants achieving CR+sCR with negative MRD per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death, or start of new anticancer therapy. |
| Secondary | Part 1 and Part 2: Concentrations of elranatamab | Assessed for approximately 2 years | Pre-dose and post-dose concentrations of elranatamab |
| Secondary | Part 1 and Part 2: Concentrations of iberdomide | Assessed for approximately 4 months | Pre-dose concentrations of iberdomide |
| Secondary | Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab | Assessed for approximately 2 years | Percent of participants with positive ADA to elranatamab when given in combination with iberdomide |
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/NCT06215118/registered