Study Design
The primary endpoints for MMY3001.
What is ORR and PFS.
The maximum duration of the treatment phase if the patients have no sign of disease progression or intolerable toxicity.
What is ~18 months.
The new system used during Feasibility for site selection.
What is illuminator.
The top 4 leading countries to get MMY3001 to FPI
What is Australia, Israel, S. Korea, and US.
The Dr. to Dr. Letter, Site referral mapping, Patient Advocacy outreach are all tactics of this.
What are resources the sites can use to find additional patients?
The stratification factors used for MMY3001.
What is ISS staging at screening , number of prior lines of therapy received and prior BCMA exposure.
The meeting where risks to critical study data are discussed.
What is de-risking.
OVAP
What is Operational Viability Assessment & Planning.
The alternative PRO collection method is being considered for MMY2001.
What is paper.
These sites may need additional training, frequent calls and extra support over the study.
What are naive sites
What is once every 4 weeks (Q4W) for 6 doses followed by once every 8 weeks (Q8W) dosing for the remainder of the treatment phase (until 18 months after start of treatment).
N=93
What is the sample size for the primary analysis in MMY2001?
MMY2001: 8 - 10
MMY3001: 16-18
What is the number of countries
3 operational Critical Path items to FPI.
What is PRO Translations, Lab Manual Readiness, IP Importation.
This service reimburses patients and caregivers for fuel costs, parking, hotels, etc.
What is travel and stipend vendor, Greenphire?
Grading of CRS and ICANS be assessed.
What is ASTCT guidelines.
This study team may be out celebrating in August after meeting FSO/FPI.
What is MMY2001.
2-8C
What is the storage condition for the Phase 3 PFS supply?
The regional difference is there between the MMY3001 study and MMY2001.
What is MMY2001 will not include APAC.