Overview

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