Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
28

Summary

Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unma...

After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated. Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Each treatment cycle lasts 28 days (4 weeks). The first two cycles are called the induction cycles. If the participant respond to treatment during the first two cycles, they can continue on to the maintenance cycles. Lenalidomide Bortezomib:

Tracking Information

NCT #
NCT02312102
Collaborators
  • Celgene Corporation
  • Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Andrew M Brunner, MD Massachusetts General Hospital