Trial · NCT03301220
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | From randomization (Day -5) up to 77 months | Intent-to-treat (ITT) analysis set included all participants randomized into the study. | Months | MEDIAN |
| SECONDARY | Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Overall Response Rate (ORR) | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Complete Response (CR) Rate | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Time to First-Line Treatment for Multiple Myeloma | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2) | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Best Response on First-line Therapy for Multiple Myeloma | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Overall Survival (OS) | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Daratumumab | Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |||
| SECONDARY | Minimum Observed Serum Concentration (Cmin) of Daratumumab | Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT( 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |||
| SECONDARY | Number of Participants With Anti-daratumumab Antibodies | Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |||
| SECONDARY | Number of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies | Cycles 1, 3, 5, 7, 12, and 24 : Predose on Day 1; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days | |||
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | From Baseline (Day -35) up to 8 years | |||
| SECONDARY | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | From Baseline (Day -35) up to 8 years | |||
| SECONDARY | Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire Score | From Baseline (Day -35) up to 8 years | |||
| SECONDARY | Duration of Response | From randomization (Day -5) up to 8 years | |||
| SECONDARY | Time to Response | From randomization (Day -5) up to 8 years |
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.
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GET https://conductscience.org/api/trials/v1/NCT03301220/outcomes