Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
- Interventional
- Active
- NCT02939183
Contact Information
(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.
A multicenter, non-randomized, open-label, dose-exploration study evaluating two new
formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed
refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate
the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate
the formulations of oprozomib administered at increasing dose levels (dose escalation) in
combination with pomalidomide and dexamethasone.
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
- 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