Featured Clinical Trial:

Multiple myeloma (product/compound: Bortezomib)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status: Enrollment closed.

Condition: Multiple Myeloma

Product Name/Compound: Bortezomib

Full Study Title: Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

Study Summary: This is a clinical trial to compare the efficacy and safety of VELCADE dexamethasone versus VELCADE, thalidomide, and dexamethasone versus VELCADE, melphalan, and prednisone in patients with previously untreated multiple myeloma who are not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.

Eligible Participants:

Inclusion (Eligible):

• Male or female subjects 18 years of age or older
• Subject is not a candidate for high-dose chemotherapy and stem cell transplantation(HDT/SCT) due to age, presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT-SCT, or subject preference.
• Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage.
• Asymptomatic multiple myeloma-related organ or tissue damage can include:
  • Presence of an asymptomatic lytic bone lesion or plasmacytoma,
  • Presence of anemia (hemoglobin < 10 g/dL),
  • Renal function impairment (serum creatinine > upper limit of normal [ULN]), or
  • Hypercalcemia (serum calcium > ULN)
• Subject must have measurable disease requiring systemic therapy. Measurable disease is defined by at least 1 of the following criteria:
  • Quantifiable serum M-protein value (>1 g/dL of IgG or IgM M-protein, >0.5g/dL of IgA M-protein, >0.5 g/dL of IgD M-protein)
  • Urine light-chain excretion ≥200 mg/24 hours

Exclusion (Not Eligible):

• Diagnosis of smoldering multiple myeloma or MGUS. Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum monoclonal protein < 3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
• Diagnosis of Waldenström's disease or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration or lytic bone lesions.
• Previously or currently treated with any systemic therapy for multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids or radiation therapy, respectively, does not disqualify the subject (the dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in 2-week period).
• Radiation therapy within 2 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
• Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery)
• History of allergy to any of the study medications, their analogues, or excipients in the various formulations
• ≥Grade 2 peripheral neuropathy on clinical examination within 21 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator. Prior to study entry, any abnormality on electrocardiogram at screening must be determined and documented by the investigator as not medically relevant.
• Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the subject has been disease-free for at least 3 years.
• Female subject who is pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test with a sensitivity of at least 50 mIU/mL during Screening.

Study Phase: Phase III (What are Phases?)

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Trial ID (ClinicalTrials.gov): NCT00507416

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