DIPSS-Intermediate or High Risk Myelofibrosis
Conditions
Brief summary
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicity (DLT), and AEs leading to discontinuation and death.
Detailed description
≥ 35% reduction in Spleen Volume Response measured by MRI or CT at the end of cycle 6 as assessed by central reader, ≥ 25% reduction in Spleen Volume Response measured by MRI or CT at the end of cycle 3 and 6 as assessed by central reader, ≥ 50% reduction in Total Symptom Score measured by MF Symptom Assessment Form (MFSAF) at the end of cycle 6
Interventions
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicity (DLT), and AEs leading to discontinuation and death. | — |
Secondary
| Measure | Time frame |
|---|---|
| ≥ 35% reduction in Spleen Volume Response measured by MRI or CT at the end of cycle 6 as assessed by central reader, ≥ 25% reduction in Spleen Volume Response measured by MRI or CT at the end of cycle 3 and 6 as assessed by central reader, ≥ 50% reduction in Total Symptom Score measured by MF Symptom Assessment Form (MFSAF) at the end of cycle 6 | — |
Countries
France, Germany, Greece, Italy, Poland, Romania, Spain
Outcome results
None listed