Trial · NCT05090566
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days) | DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each investigational product (IP) were not evaluable for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | SSB: Number of Participants With DLTs- Phase 1b | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days) | DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each IP were not evaluable for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SSA: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Severity of AEs According to Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria 2019- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Severity of AEs According to Immune Effector Cell-associated Neurotoxicity Syndrome ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Laboratory Abnormalities- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Complete Response Rate (CRR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Time to Response (TTR) as Per IMWG Criteria as Determined by Investigator-Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Duration of Response (DOR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Duration of Complete Response (DOCR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Progression Free Survival (PFS) as Per IMWG Criteria as Determined by Investigator- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Overall Survival (OS)- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Minimal Residual Disease (MRD) Negativity Rate as Per IMWG Criteria- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Pre- and Post-dose Concentrations of Elranatamab- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Trough Serum Concentrations of Nirogacestat- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Anti-drug Antibodies (ADA)- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSA: Number of Participants With Neutralizing Antibodies (NAb)- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSB: Number of Participants With TEAEs and Treatment Related TEAEs- Phase 1b | From treatment initiation till study completion | |||
| SECONDARY | SSB: Number of Participants With Severity of Adverse Events According to CRS Graded According to ASTCT Grading Criteria 2019- Phase 1b Dose Escalation | From treatment initiation till study completion |
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
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