Trial · NCT06149286
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide | Up to 35 days | Part 1 |
| Primary | Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide | Up to 2 years | Part 1 |
| Primary | Severity of TEAEs for odronextamab in combination with lenalidomide | Up to 2 years | Part 1 |
| Primary | Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) | Up to 5 years | Part 2 |
| Secondary | Odronextamab concentrations in serum | Up to 30 months | Part 1 and Part 2 |
| Secondary | Incidence of Anti-Drug Antibodies (ADA) to odronextamab | Up to 30 months | Part 1 and Part 2 |
| Secondary | Magnitude of ADAs to odronextamab | Up to 30 months | Part 1 and Part 2 |
| Secondary | Best Overall Response (BOR) as assessed by investigator review | Up to 30 months | Part 1 and Part 2 |
| Secondary | Duration of Response (DOR) as assessed by investigator review | Up to 5 years | Part 1 and Part 2 |
| Secondary | PFS as assessed by investigator review | Up to 5 years | Part 1 and Part 2 |
| Secondary | Complete Response (CR) as assessed by ICR | Up to 30 months | Part 2 |
| Secondary | BOR as assessed by ICR | Up to 30 months | Part 2 |
| Secondary | Overall Survival (OS) | Up to 5 years | Part 2 |
| Secondary | Event Free Survival (EFS) as assessed by ICR | Up to 5 years | Part 2 |
| Secondary | EFS as assessed by local investigator review | Up to 5 years | Part 2 |
| Secondary | DOR as assessed by ICR | Up to 5 years | Part 2 |
| Secondary | Time To Next anti-lymphoma Treatment (TTNT) | Up to 5 years | Part 2 |
| Secondary | Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2 | Up to 2 years | Part 2 |
| Secondary | Severity of TEAEs for odronextamab in combination with lenalidomide versus R2 | Up to 2 years | Part 2 |
| Secondary | Overall change in Patient Reported Outcomes (PROs) as measured by scores of European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQC30) | Up to 5 years | Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a Global Health Status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and GHS/QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
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/NCT06149286/registered