PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause.

The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.

Censoring rules applied:

• Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy.
• Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event.
• Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment.
• Participants without any post-baseline tumor assessments were censored on the date of randomization

All randomized participants

ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.

All randomized participants

Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").

All randomized participants

Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF).

BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).

All randomized participants

PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

All randomized participants