A Nationwide Phase 2 Trial of Patients With Smoldering and Active Multiple Myeloma (MM)
NCT03815279 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2019-08-16
Summary
The purpose of this study is to determine the efficacy of treating patients with intermediate risk smoldering multiple myeloma (SMM) with combinational therapy with dexamethasone and lenalidomide (Rd) and patients with high risk SMM with combinational therapy with Rd and carfilzomib.
Conditions
- Multiple Myeloma
- Smoldering Multiple Myeloma
Interventions
- DRUG
-
Carfilzomib will be administered intravenously three times per cycle (28 day cycles) for cycle 1-12. Thereafter twice per cycle for cycle 13-24
- DRUG
-
Lenalidomide PO once daily on days 1-21 of a 28 day cycle
- DRUG
-
Dexamethasone will be administered weekly
Sponsors & Collaborators
- collaborator INDUSTRY
-
Celgene
collaborator INDUSTRY -
University of Iceland
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
collaborator OTHER -
Landspitali University Hospital
lead OTHER
Principal Investigators
-
Sigurdur Y Kristinsson, MD, PhD · Landspitali University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-24
- Primary Completion
- 2024-01-31
- Completion
- 2028-01-31
Countries
- Iceland
Study Locations
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