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. Author manuscript; available in PMC: 2012 Aug 14.
Published in final edited form as: Br J Haematol. 2010 Jul 7;150(4):428–437. doi: 10.1111/j.1365-2141.2010.08264.x

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.