Trial · NCT05519085
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 | Progression-free Survival (PFS) | From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years) | |
| Secondary | Recommended mezigdomide dose | Up to 12 Months | Stage 1 only |
| Secondary | Plasma concentrations of mezigdomide | Up to 134 Days | Stage 1 only |
| Secondary | Overall Survival (OS) | From date of randomization to date of death due to any cause (Up to approximately 5 years) | |
| Secondary | Overall Response (OR) | Up to approximately 5 years | OR is defined as the number of participants who achieve best response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma |
| Secondary | Complete Response (CR) or better | Up to approximately 5 Years | Defined as the number of participants who achieve best response of complete response (CR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma |
| Secondary | Very Good Partial Response (VGPR) or better | Up to approximately 5 years | Defined as the number of participants who achieve best response of very good partial response (VGPR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma |
| Secondary | Time to Response (TTR) | Up to approximately 5 years | |
| Secondary | Duration of Response (DOR) | Up to approximately 5 years | |
| Secondary | Time to Progression (TTP) | Up to approximately 5 years | |
| Secondary | Time to Next Treatment (TTNT) | Up to approximately 5 years | |
| Secondary | Progression-free Survival 2 (PFS-2) | Up to approximately 5 years | |
| Secondary | Minimal Residual Disease (MRD) negativity | Up to approximately 5 years | Defined as the number of participants who achieve complete response (CR) or better and MRD negativity (defined as less than 1 in 10\^5 nucleated cells \[by next generation flow cytometry\] in bone marrow aspirate) |
| Secondary | Number of participants with Adverse Events (AEs) | Up to approximately 5 years | |
| Secondary | Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores | Up to approximately 5 years | The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only. |
| Secondary | Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score | Up to approximately 5 years | The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only. |
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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GET https://conductscience.org/api/trials/v1/NCT05519085/registered