Clinical Trial - A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) plus Thalidomide (low dose) as frontline therapy for newly diagnosed patients with Multiple Myeloma (MM)

Title:	A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) plus Thalidomide (low dose) as frontline therapy for newly diagnosed patients with Multiple Myeloma (MM)

Phase:	II

Purpose:	PRIMARY OBJECTIVES: To determine the overall response rate (CR+PR) of this novel combination, Thalidomide with VAD (Vincristine, Adriamycin, Dexamethasone) regimen. SECONDARY OBJECTIVE: To determine the ability to collect peripheral stem cells after therapy on this regimen.

Eligibility:	Patients must have a confirmed diagnosis of MM requiring therapy (Stage I - III). Patient must not have had more than one cycle of prior therapy of VAD (Vincristine, Adriamycin, Dexamethasone), not including thalidomide.

Treatment:	The treatment regimen to be used in this trial is the combination of Thalidomide and VAD (Vincristine, Adriamycin, Dexamethasone). Standard dose of the VAD (Vincristine, Adriamycin, Dexamethasone) regimen will given every 4 weeks. Thalidomide will be started at 100mg, every day, orally at bedtime on day 1 of cycle #1 or 2 of VAD and continued for 4 months (or 4 weeks after the 4th cycle of VAD regimen). Thalidomide will be stopped 10 days prior to high dose cyclophosphamide for stem cell mobilization. Those patients considered having at least a PR could be taken on to High Dose Chemotherapy (HDC) and stem cell transplantation (SCT).

Contact:	Buffalo, New York Roswell Park Cancer Institute Asher Chanan-Khan, MD 716-845-8556 asher.chanan-khan@roswellpark.org

Please note: the trials indicated do not include the full inclusion or exclusion criteria. For full protocols, please contact the Principal Investigator (PI) listed.