Multiple Myeloma Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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