Spots Global Cancer Trial Database for A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma

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Trial Identification

Brief Title: A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma

Official Title: A Multicenter, Double Arms, Prospective Phase 4 Study to Evaluating the Efficacy and Safety of Combination Therapy of PAD Versus VCD Treatment in Previously Untreated Subjects With Multiple Myeloma.

Study ID: NCT01868828

Conditions

Multiple Myeloma

Interventions

PAD

VCD

ASCT

Study Description

Brief Summary: A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, screening, treatment and follow-up.

Detailed Description: Screening At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria. Treatment Eligible patients are randomly assigned to receive either treatment PAD or VCD. All eligible subjects will be evaluated after 4 cycles treatment. According to the assessment of researchers and the willingness of patients to decide whether to autologous stem-cell transplantation (ASCT). Suitable for transplant patients will accept hematopoietic stem cell transplantation. Not suitable for transplant patients will continue accept treatment for 8 cycles. The patients who accept more than 4 cycles treatment will receive efficacy evaluation. Follow-up All patients will receive 12 months of follow-up after the treatment period. Follow-up at 4, 6, 8 and 12 month after the treatment period respectively. Subjects who have disease progression or accept other resistance myeloma therapy during the 12 months of follow-up phase will stop assessed about the study and start followed up only for survival status every 6 months through telephone interviews or to research center follow-up. All patients will accept the follow-up for survival until last case patient who complete follow-up. Safety will be evaluated throughout the study by assessment of adverse events (AEs), physical examination, vital signs and clinical laboratory findings.