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Modified Bortezomib-based Combination Therapy for Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Dexamethasone
Doxorubicin
Cyclophosphamide
Mitoxsnteone
Thalidomide
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of multiple myeloma based on standard diagnosis criteria:

    • plasmacytomas on tissue biopsy
    • bone marrow plasmacytosis
    • monoclonal immunoglobulin spike on serum electrophoresis
    • lytic bone lesions.
  • Must have relapsed or relapsed/refractory disease
  • 18 years of age or older
  • All baseline studies must be performed within 21 days of enrollment.
  • ECOG performance status of 0 to 2

Exclusion Criteria:

  • Renal insufficiency (serum creatinine levels > 2mg/dL)
  • Concomitant therapy medications that include corticosteroids
  • Peripheral neuropathy of Grade 3 or greater or painful Grade 2
  • Evidence of mucosal or internal bleeding and/or platelet refractory
  • ANC < 1000 cells/mm3
  • Hemoglobin < 8.0 g/dL
  • AST (SGOT and ALT) > 2 x ULN
  • Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
  • Known hypersensitivity to thalidomide or the development of erythema nodosum
  • Active infection or serious co-morbid medical condition
  • Pregnant or breast-feeding women
  • Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer

Sites / Locations

  • Shanghai General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

modified BZ group

conventional BZ group

Arm Description

Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide

Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide

Outcomes

Primary Outcome Measures

disease responses to treatment
Response evaluated by changes of serum M-component(g/L) through Serum quantitative immunoglobulins and Serum immunofixation electrophoresis. (g/L)

Secondary Outcome Measures

Full Information

First Posted
September 21, 2015
Last Updated
May 3, 2018
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02559154
Brief Title
Modified Bortezomib-based Combination Therapy for Multiple Myeloma
Official Title
An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

5. Study Description

Brief Summary
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.
Detailed Description
Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11. The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
modified BZ group
Arm Type
Experimental
Arm Description
Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
Arm Title
conventional BZ group
Arm Type
Active Comparator
Arm Description
Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
velcade
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Mitoxsnteone
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
disease responses to treatment
Description
Response evaluated by changes of serum M-component(g/L) through Serum quantitative immunoglobulins and Serum immunofixation electrophoresis. (g/L)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy bone marrow plasmacytosis monoclonal immunoglobulin spike on serum electrophoresis lytic bone lesions. Must have relapsed or relapsed/refractory disease 18 years of age or older All baseline studies must be performed within 21 days of enrollment. ECOG performance status of 0 to 2 Exclusion Criteria: Renal insufficiency (serum creatinine levels > 2mg/dL) Concomitant therapy medications that include corticosteroids Peripheral neuropathy of Grade 3 or greater or painful Grade 2 Evidence of mucosal or internal bleeding and/or platelet refractory ANC < 1000 cells/mm3 Hemoglobin < 8.0 g/dL AST (SGOT and ALT) > 2 x ULN Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol Known hypersensitivity to thalidomide or the development of erythema nodosum Active infection or serious co-morbid medical condition Pregnant or breast-feeding women Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Liu, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

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Modified Bortezomib-based Combination Therapy for Multiple Myeloma

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