Genmab — Oktober 2018

[E_L]

New trial: A Study of an Accelerated Infusion Rate of Daratumumab in Patients With Relapsed and Refractory Multiple Myeloma https://clinicaltrials.gov/ct2/show/NCT03697629?term=daratumumab+OR+ofatumumab+OR+tisotumab&lupd_s=10%2F05%2F2018&rank=1

[E_L]

To determine infusion related reactions in the first 6 months of daratumumab administration. Using 90min schedule.

[E_L]

and they are being cheap lol: Following the 6 monthsubjects who continue to have a response to daratumumab will be taken off study..., ..., but dara can be supplied outside of the clinical trial setting.

[E_L]

New trial: Pre-emptive Daratumumab Therapy of Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma (PREDATOR) https://clinicaltrials.gov/ct2/show/NCT03697655?term=daratumumab+OR+ofatumumab+OR+tisotumab&lupd_s=10%2F05%2F2018&rank=2

[E_L]

not sure I understand what they mean with biochemical or preclinical relapse? Anyone else?

[Solsen]

@Gentogen - Er det ikke et forudbestemt
antal events der bestemmer en interim analysis ?

[Solsen]

Altså uanset hvilken arm de kommer fra.

[dohk]

I believe biochemical relapse is M-protein detection etc and MDR relapses is established by DNA sequencing of MM clone cells. So essential protein versus DNA methods to establish relapse.

[dohk]

I would suspect that MRD relapse happens before you can measure M-protein spike, so MRD will properly be a new gold standard in the future.

[Bulder]

One of the differences between the new Canadian study and Ohio State's accelerated study, is that in the Canadian study pts get 1½ hour infusion from day one.

[Bulder]

sorry 4 hours day one

[Bulder]

and only half dose. Kind of premedication.

[gentogen]

Solsen 15:44. Jo, der er vist det mest almindelige, men jeg læste et eller andet sted, at nogle metoder kræver et mindste antal i hver arm til forskel fra en total sum

[gentogen]

I det hele taget er interim analyse lidt af en videnskab i forhold til sikkerheden af statistikken...

[Solsen]

Statistik er ikke for amatører - thats for sure !

[dohk]

Sad faktisk lige og læste lidt litteratur om event driven kliniske forsøg, ikke at jeg forstår matematikken. Men forstår at et almindelig problem er at hazard ratio antages til at være konstant gennem studiet, hvilket ikke altid gælder. Flere relapser eller dør i starten https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736164/

[dohk]

Bare læs afsnittet "Application" om Ipilimumab og forsinket af resulater.

[E_L]

that would make sense @dohk , thks, so i guess the study is designed to measure whether dosing/treating using MRD relapse works better vs chemical relapse

[Bulder]

Passer meget godt med Pollux, der lagde ud med en HR på 0,37. Den er vist siden steget til 0,44.

[polle1]

Wouw + 0,06% !!! God weekend