A Phase II study with Stimuvax® (L-BLP25 liposome vaccine) in subjects with either chemotherapy-naive, slowly progressive asymptomatic multiple myeloma or with stage II/ III multiple myeloma following...

Update Il y a 4 ans
Reference: EUCTR2006-001810-33

A Phase II study with Stimuvax® (L-BLP25 liposome vaccine) in subjects with either chemotherapy-naive, slowly progressive asymptomatic multiple myeloma or with stage II/ III multiple myeloma following chemotherapy

Woman and Man

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Extract

Primary objective: To ascertain whether vaccination with L-BLP25 induces a MUC1-specific T-cell response in subjects with either: Chemotherapy-naïve, slowly progressive, asymptomatic MM with rising (at least 10%) M-protein concentrations displayed on 2 occasions separated by an interval of at least 4 weeks, within the last 18 months, or Stage II or III MM who have experienced a treatment-free interval of at least 3 months with a stable response/plateau phase following anti-tumor therapy.


Inclusion criteria

  • Chemotherapy-naive slowly progressive asymptomatic multiple myeloma with rising (at least 10%) M-protein concentration displayed on two occasions separated by an
  • interval of at least 4 weeks within the last 18 months, or,Stage II or III multiple myeloma who have experienced a treatment-free interval of at least 3 months with a stable response/plateau phase following anti-tumor therapy

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