Bortezomib Consolidation Trial (BCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517724
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
University College, London

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2009
Actual Primary Completion Date : December 2014
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: Bortezomib consolidation
Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
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

Primary Outcome Measures :
  1. Change in Disease response [ Time Frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy ]
    Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.

  2. Number of patients with adverse events [ Time Frame: Up to 8 months after treatment start ]
    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 :
  1. assess effect of bortezomib consolidation on bone health [ Time Frame: At 1, 2, 3 and 9 months after start of treatment ]
    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

  2. assess the effect of bortezomib consolidation on Minimal Residue Disease status [ Time Frame: At 6 and 12 months post ASCT ]
  3. determine progression free survival [ Time Frame: At 2 years post ASCT ]
  4. evaluate the quality of life for patients receiving bortezomib consolidation [ Time Frame: Up to 8 months after treatment start ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01517724

United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
Principal Investigator: Kwee Yong University College, London

Responsible Party: University College, London Identifier: NCT01517724     History of Changes
Other Study ID Numbers: UCL/08/0170
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by University College, London:

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