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Trial Title:
Combination of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma
NCT ID:
NCT02027220
Condition:
Myeloma
Bortezomib
Cyclophosphamide
Dexamethasone
Granulocyte Colony-Stimulating Factor
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Cyclophosphamide
Bortezomib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
G-CSF
Description:
G-CSF Intracutaneous injection (IC) on days 0, 1, 7, 8, 14, 15, 21 and 22, every four
weeks.
Arm group label:
G-CSF/Bortez/Cyc/Dex
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Bortezomib Intravenous injection (IV) on days 1, 8, 15 and 22, every four weeks.
Arm group label:
G-CSF/Bortez/Cyc/Dex
Other name:
Velcade
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide, Continuously Intravenous injection (CIV) on days 1, 8, 15 and 22, every
four weeks.
Arm group label:
G-CSF/Bortez/Cyc/Dex
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone Intravenous injection (IV) on days 1, 2, 8, 9, 15, 16, 22 and 23, every
four weeks.
Arm group label:
G-CSF/Bortez/Cyc/Dex
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.
Detailed description:
Myeloma cells reside in specialised microenvironments, which is called myeloma niche.
Myeloma niche provides important cell-cell interactions and signalling molecules that
regulate localization and proliferation of myeloma cells. stromal cell-derived factor
1(SDF-1)/Chemokine (C-X-C Motif) Receptor 4 (CXCR4) plays an important role in this
process. G-CSF is reported to induce stem cell mobilization by decreasing bone marrow
SDF-1. Our in vitro study found that G-CSF enhanced bortezomib activity by inhibiting
SDF-1/CXCR4. Myeloma patients treated with Bortezomib, Cyclophosphamide and Dexamethasone
have achieved a relatively good response, with an ORR about 80% and complete remission
about 40%. We hypothesized that G-CSF may mobilize myeloma cells from myeloma niches thus
to enhance bortezomib activity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, aged ≥18 years, ≤ 80 years.
2. Newly diagnosed multiple myeloma according to International Myeloma Working Group.
3. Relapsed or bortezomib resistant multiple myeloma (MM), who didn't received
bortezomib during the last line of therapy for MM prior to this study.
4. Progressive disease according to International Myeloma Working Group.
5. Negative pregnancy test for female with reproductive ability.
6. Signed written informed consent.
Exclusion Criteria:
1. The patient has a history of other active malignancies within 3 years prior to study
entry.
2. The patient exhibits evidence of clinically significant uncontrolled conditions
including, but not limited to: uncontrolled systemic infection (viral, bacterial, or
fungal).
3. Female patient is pregnant or breast-feeding.
4. Known infection with HIV, active Hepatitis B or Hepatitis C.
5. The patient has a history of prior toxicity from bortezomib, cyclophosphamide or
dexamethasone that resulted in permanent discontinuation of treatments.
6. Treatment with any other investigational agent, or participation in another clinical
trial within 30 days prior to study drug administration.
7. Uncontrolled hypertension (defined as systolic blood pressure[BP] > 160 millimeters
of mercury (mmHg) or diastolic BP > 100mmHg).
8. Myocardial infarction or unstable angina within the past 6 months prior to study
drug administration. Heart failure of New York Heart Association function Class Ⅲ or
Ⅳ prior to study drug administration.
9. System illness or other severe concurrent disease or alcoholism, which, in the
judgement of the investigator, would make inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and efficacy of
investigational treatments.
10. Known or suspected of not being able to comply with the trial protocol.
11. Having been previously enrolled in this clinical trial.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Recruiting
Contact:
Last name:
jinxiang fu, doctor
Phone:
86-512-67784066
Email:
lbzwz0907@hotmail.com
Investigator:
Last name:
jinxiang fu, doctor
Email:
Principal Investigator
Start date:
December 2013
Completion date:
December 2015
Lead sponsor:
Agency:
Second Affiliated Hospital of Soochow University
Agency class:
Other
Source:
Second Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02027220
