Table VI.
Antitumour response to study treatment.
Dose group | Best response | PFS (months) | Response to prior bortezomib/no. of priors | Disposition |
---|---|---|---|---|
340 mg/m2 | Minimal response | 12·7+ | Responder/3–4 | Moved to rollover study |
175 mg/m2 | Partial response | 2·9+ | Nonresponder/3–4 | Terminated on day 95 due to unacceptable toxicity (prolonged grade 2 diarrhoea) |
175 mg/m2 | Unconfirmed partial response* | 0·9+ | Responder/>4 | Terminated due to unacceptable toxicity (grade 2 abdominal pain) |
50 mg/m2 | No change but long PFS after crossover; bone marrow from 60% plasma cell at baseline to 5% plasma cell at end of study | 2·9+, censored prior to crossover | Responder/3–4 | Crossed over to high dose on day 85 (cycle 5) and continued up to day 403 (cycle 19) |
50 mg/m2 | No change but long PFS after crossover† | 3·1+, censored prior to crossover | Responder/>4 | Crossed over to high dose on day 92, continued receiving up to day 466 (cycle 22) |
PFS, progression-free survival.
With a > 90% reduction in paraprotein observed, consistent with VGPR, by uniform criteria (2006).
Based on M protein alone.