Bortezomib Consolidation Trial (BCT)

Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Bortezomib

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disease response	Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.	At 6 and 12 months after ASCT consolidated by bortezomib therapy
Number of patients with adverse events	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	Up to 8 months after treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess effect of bortezomib consolidation on bone health	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	At 1, 2, 3 and 9 months after start of treatment
assess the effect of bortezomib consolidation on Minimal Residue Disease status		At 6 and 12 months post ASCT
determine progression free survival		At 2 years post ASCT
evaluate the quality of life for patients receiving bortezomib consolidation		Up to 8 months after treatment start

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Kwee Yong, University College, London

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: bortezomib; MM; ASCT; consolidation; HDT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Bortezomib
• Other Study ID Numbers: UCL/08/0170