Combination of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma
NCT02027220 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2014-01-06
Summary
RATIONALE: Bortezomib may stop the growth of myeloma cells by blocking proteasome activity. Cyclophosphamide and dexamethasone may work in different ways to stop the growth of myeloma cells by stopping them from dividing or by killing the cells. Granulocyte Clone Stimulating Factor (G-CSF) possesses the ability to mobilize the plasma cells to detach from myeloma niche, so as to promote drug sensitivity.
PURPOSE: This phase Ⅱ trial is to study how well combination of G-CSF, bortezomib, cyclophosphamide and dexamethasone works in treating patients with multiple myeloma.
Conditions
- Myeloma
- Bortezomib
- Cyclophosphamide
- Dexamethasone
- Granulocyte Colony-Stimulating Factor
Interventions
- DRUG
-
G-CSF
G-CSF Intracutaneous injection (IC) on days 0, 1, 7, 8, 14, 15, 21 and 22, every four weeks.
- DRUG
-
Bortezomib Intravenous injection (IV) on days 1, 8, 15 and 22, every four weeks.
- DRUG
-
Cyclophosphamide, Continuously Intravenous injection (CIV) on days 1, 8, 15 and 22, every four weeks.
- DRUG
-
Dexamethasone Intravenous injection (IV) on days 1, 2, 8, 9, 15, 16, 22 and 23, every four weeks.
Sponsors & Collaborators
-
Second Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Jinxiang Fu, M.D., PhD · Second Affiliated Hospital of Soochow University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- China
Study Locations
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