Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigators planned to accrue 176 participants, to compare the response rate, overall response rate and survival of patients with multiple myeloma (MM) when randomized to two regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment (i.e. increase in complete response rates).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Novartis
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diphosphonates; Doxorubicin; Liposomal doxorubicin; Thalidomide; Vincristine; Zoledronic Acid

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