Bortezomib Consolidation Trial

NCT01517724 | Completed Phase 2 DMC

• 1 other identifier: UCL/08/0170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

MM; HDT; ASCT; consolidation; bortezomib

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• assess effect of bortezomib consolidation on bone health

  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

Study Arms (1)

Bortezomib consolidation

EXPERIMENTAL

Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)

Drug: Bortezomib

Interventions

Bortezomib DRUG

1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles

Also known as: Velcade

Bortezomib consolidation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

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

Study Officials

• Kwee Yong

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 25, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: January 24, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-03

Locations

GB (1)