Combination of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma

NCT02027220 | Unknown Phase 2 DMC

• 1 other identifier: GBCD-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Defined as the portion of patients whose best response is equal to or better than partial response (PR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to International Myeloma Working Group (IMWG). Response was confirmed after every cycle of treatment. Stringent complete response (sCR): Normal free light chain (FLC) ration, plus criteria for complete response. Complete response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in the bone marrow. Very Good Partial Response(VGPR): Positive immunofixation but negative electrophoresis; ≥90% reduction in serum M-component; Urine M-component ≤ 100mg per 24 hours. Partial Response (PR): ≥50% reduction in serum M-component and/or Urine M-component ≥90% reduction or \< 200mg per 24 hours.

  4 months

Secondary Outcomes (4)

• Number of participants with treatment related adverse events.

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• Overall Survival (OS)

  2 years

• Progression Free Survival (PFS)

  2 years

• Duration of Response (DOR)

  2 years

Study Arms (1)

G-CSF/Bortez/Cyc/Dex

EXPERIMENTAL

G-CSF IC on days 0, 1, 7, 8, 14, 15, 21 and 22. Bortezomib IV on days 1, 8, 15 and 22. Cyclophosphamide CIV on days 1, 8, 15 and 22. Dexamethasone IV on days 1, 2, 8, 9, 15, 16, 22 and 23.

Drug: G-CSF; Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone

Interventions

G-CSF DRUG

G-CSF Intracutaneous injection (IC) on days 0, 1, 7, 8, 14, 15, 21 and 22, every four weeks.

G-CSF/Bortez/Cyc/Dex

Bortezomib DRUG

Bortezomib Intravenous injection (IV) on days 1, 8, 15 and 22, every four weeks.

Also known as: Velcade

G-CSF/Bortez/Cyc/Dex

Cyclophosphamide DRUG

Cyclophosphamide, Continuously Intravenous injection (CIV) on days 1, 8, 15 and 22, every four weeks.

G-CSF/Bortez/Cyc/Dex

Dexamethasone DRUG

Dexamethasone Intravenous injection (IV) on days 1, 2, 8, 9, 15, 16, 22 and 23, every four weeks.

G-CSF/Bortez/Cyc/Dex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years, ≤ 80 years.
• Newly diagnosed multiple myeloma according to International Myeloma Working Group.
• Relapsed or bortezomib resistant multiple myeloma (MM), who didn't received bortezomib during the last line of therapy for MM prior to this study.
• Progressive disease according to International Myeloma Working Group.
• Negative pregnancy test for female with reproductive ability.
• Signed written informed consent.

You may not qualify if:

• The patient has a history of other active malignancies within 3 years prior to study entry.
• The patient exhibits evidence of clinically significant uncontrolled conditions including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal).
• Female patient is pregnant or breast-feeding.
• Known infection with HIV, active Hepatitis B or Hepatitis C.
• The patient has a history of prior toxicity from bortezomib, cyclophosphamide or dexamethasone that resulted in permanent discontinuation of treatments.
• Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
• Uncontrolled hypertension (defined as systolic blood pressure\[BP\] \> 160 millimeters of mercury (mmHg) or diastolic BP \> 100mmHg).
• 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.
• 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.
• Known or suspected of not being able to comply with the trial protocol.
• Having been previously enrolled in this clinical trial.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Granulocyte Colony-Stimulating Factor; Bortezomib; Cyclophosphamide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jinxiang Fu, M.D., PhD

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jinxiang fu, Doctor

CONTACT

86-512-67784-66; lbzwz0907@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: December 21, 2013
• First Posted: January 6, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

CN (1)