This trial is active, not recruiting.

Condition multiple myeloma
Treatment bortezomib
Phase phase 2
Target proteasome
Sponsor University College, London
Start date December 2009
End date December 2014
Trial size 40 participants
Trial identifier NCT01517724, UCL/08/0170


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
bortezomib Velcade
1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles

Primary Outcomes

Change in Disease response
time frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy
Number of patients with adverse events
time frame: Up to 8 months after treatment start

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
Principal investigator Kwee Yong
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University College, London.