Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma

• Status: Withdrawn
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Proteasome Inhibitors

Criteria

Inclusion Criteria:

• Symptomatic, histologically confirmed MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:

• Serum M-protein ≥ 1.0 g/dL by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative IgA; or

• Urinary M-protein excretion at least 200 mg/24 hours; or

• Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal.

• If serum protein electrophoresis is felt to be unreliable for routine M- protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable.

• Must have received ≥ 2 prior anti-MM therapies including a proteasome inhibitor and an IMiD. The most recent proteasome inhibitor must not have been carfilzomib.

• Patients previously treated with carfilzomib are eligible as long as they meet the following criteria:

• Not received carfilzomib within 6 months (183 days) of Cycle 1 Day 1 (C1D1), and

• Carfilzomib was not part of their most recent therapy for the treatment of MM, and

• Did not discontinue carfilzomib treatment because of adverse effects.

• MM that is refractory to the most recent treatment regimen. Refractory is defined as ≤ 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy.

Exclusion Criteria:

• Smoldering MM.

• Active plasma cell leukemia.

• MM that does not express M-protein or serum FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or serum FLC are excluded).

• Documented active systemic amyloid light chain amyloidosis.

• Active MM involving the central nervous system.

• Active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.

• Prior autologous stem cell transplantation < 1 month or allogenic stem cell transplantation < 3 months prior to C1D1.

• Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.