Clinical trial NCT00215943 (phase 3, status: terminated)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: zoledronic acid, dexamethasone, thalidomide, vincristine, adriamycin
SMILES: OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O, 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, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Reason stopped: 
    poor accrual, changes in management of newly diagnosed myeloma patients, new drugs/more
    effective regimens.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have newly diagnosed MM confirmed by the presence of bone marrow
             plasmacytosis with > 10 percent plasma cells, sheets of plasma cells, or biopsy-proven
             plasmacytoma. Patients must have Durie-Salmon Stage IIA-B or IIIA-B. Patients with
             non-secretory myeloma are eligible. (These patients will not be included in the
             analysis of response rates, but will be assessed for toxicity and survival).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3

          -  ≥ 18 years of age.

          -  Signed informed consent form

          -  Expected survival of greater than 8 weeks

          -  Capable of swallowing study medication tablets

          -  Capable of following directions regarding taking study medication, or has a daily care
             provider who will be responsible for administering study medication.

          -  Patients will be eligible for study even if they lack socioeconomic access to
             autologous transplantation. (These patients will be identified prior to randomization
             so as not to confound study results).

          -  All patients (in the event that they are randomized to the thalidomide/dexamethasone
             arm) must agree to take part in the "System for Education and Prescribing Safety"
             (S.T.E.P.S.)™. They must sign a separate informed consent for this program.

        Exclusion Criteria:

          -  Elevated direct bilirubin > 2 mg/dl

          -  Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) > 2
             times the upper limit of normal (ULN)

          -  Absolute neutrophil count (ANC) <1000/mL, unless felt to be secondary to myeloma

          -  Ongoing radiation therapy, or radiation therapy within 3 weeks prior to first
             treatment, unless the acute side effects associated with such therapy are resolved.

          -  Prior treatment for multiple myeloma

          -  Prior bisphosphonate use is allowed but they must be discontinued before starting
             treatment.

          -  Concurrent uncontrolled serious infection

          -  Patients with peripheral (sensory) neuropathy, grade 3 or higher

          -  Life-threatening illness (unrelated to tumor)

          -  History of any other ACTIVE and INVASIVE cancer other than the present condition
             (except non-melanoma skin cancer), unless in complete remission and off of all therapy
             for that disease for a minimum of 3 years.

          -  Women of childbearing potential (unless utilizing birth control) or who are pregnant
             or nursing will be excluded from this study.

          -  Patients with comorbid conditions that would contraindicate the use of vincristine,
             doxorubicin, dexamethasone, thalidomide, or zoledronate.

          -  Plasma Cell Leukemia