Bortezomib Consolidation Trial

Multiple Myeloma Clinical Trial

— BCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517724
• Other study ID #: UCL/08/0170
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: January 24, 2019

Study information

• Verified date: March 2019
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 24, 2019
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	assess the effect of bortezomib consolidation on Minimal Residue Disease status		At 6 and 12 months post ASCT
Secondary	determine progression free survival		At 2 years post ASCT
Secondary	evaluate the quality of life for patients receiving bortezomib consolidation		Up to 8 months after treatment start