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

Phase 2
18 Years
70 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Disease response

Outcome Description:

Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.

Outcome Time Frame:

At 6 and 12 months after ASCT consolidated by bortezomib therapy

Safety Issue:


Principal Investigator

Kwee Yong

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College, London


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

December 2009

Completion Date:

December 2015

Related Keywords:

  • Multiple Myeloma
  • MM
  • HDT
  • ASCT
  • consolidation
  • bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell