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Bortezomib Consolidation Trial (BCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01517724
First received: December 20, 2011
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Change in Disease response [ Time Frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy ] [ Designated as safety issue: No ]
    Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.

  • Number of patients with adverse events [ Time Frame: Up to 8 months after treatment start ] [ Designated as safety issue: Yes ]
    The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT


Secondary Outcome Measures:
  • assess effect of bortezomib consolidation on bone health [ Time Frame: At 1, 2, 3 and 9 months after start of treatment ] [ Designated as safety issue: No ]
    Summary of changes from baseline, after cycle 1,2 and 3 of bortezomib treatment and at the end of treatment for markers of bone formation and resorption

  • assess the effect of bortezomib consolidation on Minimal Residue Disease status [ Time Frame: At 6 and 12 months post ASCT ] [ Designated as safety issue: No ]
  • determine progression free survival [ Time Frame: At 2 years post ASCT ] [ Designated as safety issue: No ]
  • evaluate the quality of life for patients receiving bortezomib consolidation [ Time Frame: Up to 8 months after treatment start ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bortezomib
    1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
    Other Name: Velcade
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed
  • Age 18 - 70 years
  • Life expectancy > 6 months
  • Written informed consent
  • Creatinine < 400µmol/L
  • Bilirubin < 3x upper limit of normal
  • WHO performance status 0-2
  • Contraceptive precautions where appropriate

Exclusion Criteria:

  • Received bortezomib previously
  • On, or planned for, steroid therapy
  • Poor performance status (ECOG ≥ 3)
  • Disease progression at any stage
  • Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2
  • Severe hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST > 2.5x upper limit of normal
  • Pregnant or lactating women
  • Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol
  • Severe cardiovascular disease
  • History of acute infiltrative pulmonary or pericardial disease
  • History of hypotension or has decreased blood pressure
  • Peripheral neuropathy ≥ grade 2, or neuropathic pain
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Received any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib
  • Need for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors
  • Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517724

Contacts
Contact: BCT Trial Coordinator +44 207 679 9860 bct@ctc.ucl.ac.uk

Locations
United Kingdom
University College London Recruiting
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Kwee Yong University College, London
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01517724     History of Changes
Other Study ID Numbers: UCL/08/0170
Study First Received: December 20, 2011
Last Updated: January 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University College, London:
MM
HDT
ASCT
consolidation
bortezomib

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014