Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .
Reversibility of symptomatic peripheral neuropathy with bortezomib in the phase III APEX trial in relapsed multiple myeloma: impact of a dose‐modification guideline
The frequency , characteristics and reversibility of bortezomib‐associated peripheral neuropathy were evaluated in the phase III APEX ( Assessment of Proteasome Inhibition for Extending Remissions ) trial in patients with relapsed myeloma , and the impact of a dose‐modification guideline on peripheral neuropathy severity and reversibility was assessed . Patients received bortezomib 1·3 mg/m2 ( days 1 , 4 , 8 , 11 , eight 21‐d cycles , then days 1 , 8 , 15 , 22 , three 35‐d cycles ) ; bortezomib was held , dose‐reduced or discontinued depending on peripheral neuropathy severity , according to a protocol ‐specified dose‐modification guideline . Overall , 124/331 patients ( 37 % ) had treatment‐emergent peripheral neuropathy , including 30 ( 9 % ) with grade ≥3 ; incidence and severity were not affected by age , number/type of prior therapies , baseline glycosylated haemoglobin level , or diabetes history . Grade ≥3 incidence appeared lower versus phase II trials ( 13 % ) that did not specifically provide dose‐modification guidelines . Of patients with grade ≥2 peripheral neuropathy , 58/91 ( 64 % ) experienced improvement or resolution to baseline at a median of 110 d , including 49/72 ( 68 % ) who had dose modification versus 9/19 ( 47 % ) who did not . Efficacy did not appear adversely affected by dose modification for grade ≥2 peripheral neuropathy . Bortezomib‐associated peripheral neuropathy is manageable and reversible in most patients with relapsed myeloma . Dose modification using a specific guideline improves peripheral neuropathy management without adversely affecting outcome
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .