Gender
All
Age Group
18 Years to 100 Years
Accepting Healthy Volunteers
No
Inclusion criteria
- Subject must have a pathologically documented, definitively diagnosed, multiple
myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy
for multiple myeloma. Prior therapeutic treatment or regimens must include a
proteasome inhibitor and lenalidomide.
- Subject must be willing and able to undergo bone marrow aspirate per protocol (with or
without bone marrow biopsy per institutional guidelines).
- Measurable disease (assessed within 28 days prior to day 1)
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- Other Inclusion Criteria May Apply
Exclusion Criteria
- Currently receiving treatment in another investigational device or drug study, or less
than 28 days or 5 half-lives whichever is shorter since ending treatment on another
investigational device or drug study(s).
- Previously received an allogeneic stem cell transplant and the occurrence of one or
more of the following: received the transplant within 6 months prior to study day
1;received immunosuppressive therapy within the last 3 months prior to study day
1;having signs or symptoms of acute or chronic graft-versus-host disease.
- Autologous stem cell transplant < 90 days prior to study day 1.
- Multiple myeloma with IgM subtype.
- POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes).
- Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
- Waldenstrom's macroglobulinemia.
- Other Exclusion Criteria May Apply
