Myelofibrosis
Conditions
Keywords
BMS-986158, Fedratinib, Myelofibrosis, Ruxolitinib
Brief summary
The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.
Interventions
DRUGBMS-986158
Specified dose on specified days
DRUGRuxolitinib
Specified dose on specified days
DRUGFedratinib
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis * Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment * Must agree to follow specific methods of contraception, if applicable
Exclusion criteria
* Women who are pregnant or breastfeeding at screening * Any significant acute or uncontrolled chronic medical illness Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to 52 months |
| Incidence of serious adverse events (SAEs) | Up to 52 months |
| Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | Up to 26 months |
| Incidence of AEs leading to discontinuation | Up to 52 months |
| Incidence of death | Up to 52 months |
Secondary
| Measure | Time frame |
|---|---|
| Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR) | Up to 175 days |
| Additional measures based on TSS measured by MFSAF | Up to 175 days |
| Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR | Up to 175 days |
| SVR at end of Cycle 3 and 6 assessed by BICR | Up to 175 days |
| Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR | Up to 175 days |
| Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF) | Up to 175 days |
Countries
Australia, France, Germany, Greece, Hungary, Israel, Italy, Poland, Romania, South Korea, Spain, United States
Outcome results
None listed