Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2021-12-23
• Target enrollment: 0
• Participant gender: All

Summary

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pomalidomide; Thalidomide

Criteria

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