What we are studying
You have been asked to take part in this study because you have been diagnosed with myelodysplastic syndrome. Myelodysplastic syndrome is a type of cancer that affects how blood cells are made.
This study has 2 separate parts. About 200 patients in total will participate in this worldwide study: about 30 patients in Part 1 and about 170 patients in Part 2.
All patients participating in Part 1 of this study will get 7.5 mg/kg of imetelstat as a 2-hour intravenous infusion once every 4 weeks.
Not everyone in Part 2 of the study will get imetelstat. There are two treatment groups in this study:
• Patients in Treatment Group A will receive 7.5 mg/kg of imetelstat given in a vein for 2 hours once every 4 weeks. Before receiving imetelstat, you will receive 25-50mg of diphenhydramine (an antihistamine) and 100-200 mg of hydrocortisone (a corticosteroid), or equivalent.
• Patients in Treatment Group B will receive placebo given in your vein for 2 hours once every 4 weeks. Before receiving placebo, you will receive 25-50mg of diphenhydramine (an antihistamine) and 100-200 mg of hydrocortisone (a corticosteroid), or equivalent.
The amount of time you will be in the study may vary. This is because you will remain in the study and continue to take the study drug for as long as it is helping you. The study will last approximately 2 years after the last patient has been enrolled into the study
Patients will be reimbursed for travel expenses, parking and meals.