Phase 1, Multicenter, Open-label, Dose-escalation Study of ACE-011 in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
After the screening procedures confirm that you are eligible to participate in the research
Assignment to dose level of study treatment Since we are looking for the highest dose of the
ACE 011 combined with lenalidomide that can be administered safely without severe or
unmanageable side effects in participants that have multiple myeloma, not everyone who
participates in this research study will receive the same dose of these drugs. The dose you
get will depend on the number of participants who have been enrolled in the study before you
and how well they have tolerated their doses.
Study treatment Study treatment will be given in 28 day cycles.
- ACE-011 will be given as an injection under the skin, Day 1 of each cycle (every 28
days). You will receive each injection at the clinic.
- Lenalidomide will be taken by mouth: once daily days 1 21, followed by a 7 day rest
period during which no lenalidomide will be taken.
- Dexamethasone will be taken by mouth once per week (days 1, 8, 15 and 22) of each
You will be given drug diaries to record the doses of lenalidomide and dexamethasone taken.
The study staff will tell you how to complete the diaries
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose of ACE-011
Identify the maximum tolerated dose of ACE-011 given in combination with lenalidomide and dexamethasone in subejcts with relapsed multiple myeloma
Anuj Mahindra, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hosptial||Boston, Massachusetts 02114|