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.
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.
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
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
Complete Response Rate
Up to cycle 4 (with 28 days per cycle).
Jin Lu, PhD
Peking University People's Hospital
China: Food and Drug Administration
PAD VS VCD Clinical Protocol