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

Stopped early · Phase 3

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT00215943

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

90

Starts

2003-06-01

Expected to finish

2012-08-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Morton Plant Hospital — Clearwater, Florida, United States
• Watson Clinic — Lakeland, Florida, United States
• Fawcett Memorial Hospital — Port Charlotte, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• San Juan VA Hospital — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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