Clinical trial NCT01134484 (phase 3, status: unknown status)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: velcade, thalidomide, dexamethasone
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F
Eligibility criteria:

        Inclusion criteria:

          -  Confirmed diagnosis of symptomatic MM based on standard criteria.

          -  No prior or current systemic therapy for MM, including steroids.

          -  At least 18 years and less than 65 years of age.

          -  Presence of quantifiable M protein in serum (e.g. greater than 1 g/dL for IgG MM,
             greater than 0.5 g/dL of IgA or IgD MM) or urine (e.g. greater than 200 mg/day for BJ
             MM).

          -  Karnofsky performance status (PS) at least 60%.

          -  Willing and able to comply with the protocol requirements.

          -  Agreement from both male and female patients to follow the risk management program
             established for the prevention of pregnancy, including double methods for
             contraception and beta-HCG tests for women of childbearing potential and contraception
             for males.

          -  Adequate organ function, including heart, liver, kidney (serum creatinine less than 2
             mg/dL)

          -  Platelet count at least 70 x 10/mcL and absolute neutrophil count at least 1 x 10/mcl

        Exclusion criteria:

          -  Diagnosis of asymptomatic MM or of MGUS based on standard criteria.

          -  Diagnosis of non-secretory MM.

          -  Diagnosis of AL Amyloidosis.

          -  Prior or current systemic therapy for MM, including steroids (with exception of
             bisphosphonates).

          -  Patient has received other investigational drugs within 30 days before enrollment.

          -  Female subjects pregnant or breastfeeding

          -  Patient has Grade 2 or higher peripheral neuropathy (NCI criteria).

          -  Patient has a prior history of thrombosis or venous thromboembolism or pulmonary
             embolism.

          -  Patient has a previous diagnosis of antiphospholipid antibodies or lupus
             anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin,
             protein C or S deficiency.

          -  Patient has a clear indication to receive a specific other anti-platelet therapy (e.g.
             clopidogrel, ticlopidine).

          -  Patient has a clear indication to receive long-term anticoagulant therapy (e.g.
             prosthetic heart valve, atrial fibrillation).

          -  Active bleeding or high risk of bleeding (gastrointestinal bleeding within the past 12
             months; endoscopic diagnosis of peptic ulcer disease or ulcerative esophagitis within
             the past 6 months unless there is documented endoscopic evidence of healing;
             intracranial bleeding within the past year; amyloidosis; known bleeding diathesis).

          -  Seropositive for HIV, or active hepatitis A, B or C infection.

          -  Poorly controlled hypertension or diabetes mellitus (if receiving antidiabetic agents,
             subjects must be on a stable dose for at least 3 months before the start of therapy)
             or other serious medical or psychiatric conditions that could interfere with adherence
             to or completion of this study.

          -  Patient has hypersensitivity to bortezomib, boron or mannitol.

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study

          -  Previous or concurrent malignancies at other sites, with the exception of
             appropriately treated localized epithelial skin or cervical cancer. Patients with
             remote histories (>5 years) of other cured tumors may be entered.

          -  Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic
             therapy within 4 weeks before enrolment.