Modified Bortezomib-based Combination Therapy for Multiple Myeloma

NCT02559154 | Unknown Phase 4

• 1 other identifier: 2010K059
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• disease responses to treatment

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

  one year

Study Arms (2)

modified BZ group

EXPERIMENTAL

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

conventional BZ group

ACTIVE COMPARATOR

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

Interventions

Bortezomib DRUG

Also known as: velcade

conventional BZ group; modified BZ group

Dexamethasone DRUG

conventional BZ group; modified BZ group

Doxorubicin DRUG

conventional BZ group; modified BZ group

Cyclophosphamide DRUG

conventional BZ group; modified BZ group

Mitoxsnteone DRUG

conventional BZ group; modified BZ group

Thalidomide DRUG

conventional BZ group; modified BZ group

Eligibility Criteria

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

You may qualify if:

• 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
• years of age or older
• All baseline studies must be performed within 21 days of enrollment.
• ECOG performance status of 0 to 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, 200080, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Dexamethasone; Doxorubicin; Cyclophosphamide; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guohua Liu, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Doctor

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 24, 2015
• Study Start: July 1, 2010
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

CN (1)