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Modified Bortezomib-based Combination Therapy for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02559154
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Daolin Wei, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Drug: Dexamethasone Drug: Doxorubicin Drug: Cyclophosphamide Drug: Mitoxsnteone Drug: Thalidomide Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma
Study Start Date : July 2010
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: modified BZ group
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
Drug: Bortezomib
Other Name: velcade

Drug: Dexamethasone
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Mitoxsnteone
Drug: Thalidomide
Active Comparator: conventional BZ group
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
Drug: Bortezomib
Other Name: velcade

Drug: Dexamethasone
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Mitoxsnteone
Drug: Thalidomide



Primary Outcome Measures :
  1. disease responses to treatment [ Time Frame: one year ]

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

    (g/L)




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559154


Locations
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China
Shanghai General Hospital
Shanghai, China, 200080
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Guohua Liu, MD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Daolin Wei, Principal Investigator,Doctor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02559154     History of Changes
Other Study ID Numbers: 2010K059
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Bortezomib
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones