A Phase 2, Randomized Study of VELCADE® (Bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (Bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who Are Candidates for Autologous Transplantation
- Male or female between ≥18 and ≤70 years
- Patient is a candidate for HDT combined with an autologous SCT
- Karnofsky Performance Status score of ≥60%
- Multiple myeloma diagnosed according to the following standard criteria AND requiring
- Presence of M-component in serum and/or urine, plus clonal plasma cells in the bone
marrow and/or a documented clonal plasmacytoma
- PLUS 1 or more of the following:
1. Calcium elevation (>11.5 mg/dL or >2.65 mmol/L)
2. Renal insufficiency (creatinine >2 mg/dL or >177 umol/L)
3. Anemia (hemoglobin <10 g/dL [<12.5 mmol/L] or at least 2 mg/dL [1.25 mmol/L]
4. Bone disease (lytic lesions or osteopenia)
- AND fulfill criteria for measurable disease, as defined by at least 1 of the
following 3 measurements:
1. Serum M-protein ≥1 g/dL (≥10 g/L)
2. Urine M-protein ≥200 mg/24 h
3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L)
provided serum FLC ratio is abnormal
- Women of childbearing potential must agree to use 2 methods of contraception.
- Males must agree to use barrier contraception.
- Subjects (or their legally acceptable representatives) must have signed an informed
- To participate in the optional pharmacogenomic component of this study, subjects (or
their legally acceptable representative) must have signed the informed consent form.
Refusal to consent for this component does not exclude a subject from participation
in the clinical study.
- Diagnosis of smoldering OR non-secretory multiple myeloma or monoclonal gammopathy of
undetermined significance (MGUS).
- Diagnosis of Waldenström's disease or other conditions in which IgM M-protein is
present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- Prior or current systemic therapy for multiple myeloma including steroids.
- Radiation therapy and/or plasmapheresis within 15 days before randomization.
- History of allergic reaction attributable to compounds being given (VELCADE,
thalidomide, dexamethasone, and/or cyclophosphamide) or compounds containing boron or
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version
- Uncontrolled or severe cardiovascular disease
- Concurrent medical condition or disease (e.g., active systemic infection,
uncontrolled diabetes) that is likely to interfere with study procedures or results,
or that in the opinion of the investigator would constitute a hazard for
participating in this study.
- Use of any investigational drugs within 30 days before randomization
- Pregnant or lactating women: A serum β-hCG pregnancy test must be performed at the
Screening visit for female subjects of childbearing potential.
- Employees of the investigator or study center, with direct involvement in the
proposed study or other studies under the direction of that investigator or study
center, as well as family members of the employees or the investigator.