Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects must satisfy all of the following criteria to be enrolled in the study:
1. Subject is newly diagnosed and has symptomatic Multiple Myeloma (MM) prior to initiating induction anti-myeloma therapy
2. Subject is ≥ 18 years of age at the time of initial diagnosis of MM
3. Subject has measurable disease at initial diagnosis by
* M-protein and/or
* Light chain MM without measurable disease in the serum or urine
4. Subject has high-risk MM at the time of initial diagnosis of MM per R-ISS Stage III as defined by IMWG:
* ISS Stage III and cytogenetic abnormalities with t(4; 14) and/or del(17p); and/or t(14:16) by iFISH; or;
* ISS Stage III and serum LDH \> ULN
5. Subject has Eastern Cooperative Oncology Group performance ≤ 1
6. Subjects has received ≤ to 3 cycles of the following induction anti-myeloma therapy prior to enrollment:
* Cycle 1: one of the following regimens (RVd, KRd, CyBorD, D-RVd and D-KRd)
* Cycle 2 to Cycle 3: either KRd or RVd (Cycle 3 must be without dexamethasone)
You may not be if
The presence of any of the following will exclude a subject from enrollment: The presence of any of the following will exclude a subject from enrollment:
At initial diagnosis, screening and prior to initiation of induction therapy for MM:
1. Subject has non-secretory MM
During Screening:
2. Subject received any treatments for MM other than up to 3 cycles of induction therapy per protocol
3. Subject has any of the following laboratory abnormalities:
