Trial · NCT05675449
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 50
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 Number of participants with dose limiting toxicity (DLT) | From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days. | Dose limiting toxicity rate based on dose limiting toxicity evaluable participants. |
| Primary | Part 2A Number of participants with dose limiting toxicity | From the first dose of maplirpacept through the first cycle of combination treatment, about 64 days. | Dose limiting toxicity based on dose limiting toxicity evaluable participants. |
| Primary | Part 2B Number of participants with dose limiting Toxicity | From first dose of elranatamab through the first cycle of combination treatment, about 42 days. | Dose limiting toxicity rate based on dose limiting toxicity evaluable participants. |
| Secondary | Part 1: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment | Assessed from baseline up to 90 days after last dose of study treatment. | Counts of participants who had TEAEs, defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Secondary | Part 1: 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 possibility of causal relationship. |
| Secondary | Part 1: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities | Accessed from baseline up to 90 days after the last dose of study treatment. | Laboratory abnormalities as characterized by type, frequency, severity. |
| Secondary | Part 1: Percent of participants with Best Overall Response (BOR) | Assessed for approximately 2 years | BOR is defined as the best response recorded from treatment start until disease progression/recurrence based on International Myeloma Working Group (IMWG) response criteria. |
| Secondary | Part 1: Percentage of Participants with an Objective Response Rate (ORR) | Assessed from enrollment for approximately 2 years. | ORR rate is defined as the percent of participants having a Best Overall Response (BOR) of confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) according to IMWG. |
| Secondary | Part 1: Percentage of participants with a complete response rate (CRR) | Assessed for approximately 2 years | Complete Response/ stringent Complete Response (CR+sCR) rate per IMWG response criteria as determined by investigator. |
| Secondary | Part 1: Time to Response (TTR) | Assessed for approximately 2 years. | TTR is defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed. |
| Secondary | Part 1: Duration of Response (DOR) | Assessed for approximately 2 years. | DOR is defined, for participants with an objective response per IMWG criteria, as the time from the first documentation of objective response that is subsequently confirmed, until the first documentation of confirmed progressive disease (PD) per IMWG criteria. |
| Secondary | Part 1: Duration of Complete Response (DOCR) | Assessed for approximately 2 years. | DOCR is defined, for participants with a Complete Response/stringent Complete Response (CR+sCR) per IMWG criteria, as 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: Time of Progression Free Survival (PFS) | Assessed from enrollment until Progressive Disease or death for approximately 2 years. | Progression free survival (IMWG response criteria) |
| Secondary | Part 1: Time of Overall Survival (OS) | Assessed for approximately 2 years | OS is the duration of time from first dose of study treatment to death. |
| Secondary | Part 1: Minimal Residual Disease (MRD) Negativity Rate | Assessed for approximately 2 years | MRD negativity rate is the proportion of participants acheiving 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: Concentrations of carfilzomib | Once approximately 7 weeks from enrollment. | Pre-dose and post-dose concentrations of cafilzomib |
| Secondary | Part 1: Concentrations of elranatamab | Assessed for approximately 2 years. | Pre-dose and post-dose concentrations of elranatamab |
| Secondary | Part 1: 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 carfilzomib and dexamethasone |
| Secondary | Part 2A: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment | Assessed from baseline up to 90 days after last dose of study treatment. | Counts of participants who had TEAEs, defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Secondary | Part 2A: 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 possibility of causal relationship. |
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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