Trial · NCT04570631
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 | Recommended Phase 2 Dose (RP2D) of Eftozanermin Alfa in Combination With Bortezomib and Dexamethasone (Safety Lead-In Arm) | Up to approximately 3 weeks after the first dose of study drug | RP2D of eftozanermin alfa in combination with bortezomib and dexamethasone will be determined. |
| Primary | Objective Response Rate (ORR) (Dose Expansion Arm) | Up to approximately 44 weeks after the first dose of study drug | ORR is defined as percentage of participants with a response of partial response (PR) or better per International Myeloma Working Group (IMWG) criteria. |
| Secondary | Rate of Very Good Partial Response (VGPR) or Better per IMWG Criteria | Up to approximately 44 weeks after the first dose of study drug | Percentage of participants with a response of VGPR or better per IMWG criteria will be assessed. |
| Secondary | Duration of Response (DOR) for ORR | Up to approximately 44 weeks after the first dose of study drug | DOR for ORR is defined as the number of days from the date of first response (PR or better) to the date of first occurrence of progressive disease (PD) or death from any cause, whichever occurs first. |
| Secondary | Duration of Response (DOR) for VGPR or Better | Up to approximately 44 weeks after the first dose of study drug | DOR for VGPR or better rate is defined as the number of days from the date of first response (VGPR or better) to the date of first occurrence of PD or death from any cause, whichever occurs first. |
| Secondary | Number of Participants With Dose-Limiting Toxicities (DLTs) | Up to approximately 3 weeks after the first dose of study drug | DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of study drug as described in the protocol and evaluated by the Investigator and the sponsor. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to approximately 44 weeks after the first dose of study drug | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. |
| Secondary | Change in Vital Sign Measurements | Up to approximately 44 weeks after the first dose of study drug | Change from baseline in vital sign measurements such as systolic and diastolic blood pressure will be assessed. |
| Secondary | Electrocardiogram (ECG) | Up to approximately 44 weeks after the first dose of study drug | Participants with change from baseline in ECG variables will be assessed. |
| Secondary | Number of Participants With Abnormal Clinical Laboratory Test Results | Up to approximately 44 weeks after the first dose of study drug | Number of participants with abnormal clinical laboratory test results like hematology will be assessed. |
| Secondary | Trough Concentration (Ctrough) of Eftozanermin Alfa | Up to Day 106 | Serum concentration prior to administration of study drug. |
| Secondary | Maximum Serum Concentration (Cmax) of Eftozanermin Alfa | Up to Day 8 | Serum concentration at 15 min after end of infusion. |
| Secondary | Antidrug Antibody (ADA)/Neutralizing Antibody (Nab) Assay | Up to approximately 44 weeks after the first dose of study drug | Serum sample assay for ADA/Nab (Nabs will be analyzed only upon request). |
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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