PCRC_A061202

A PHASE I/II STUDY OF POMALIDOMIDE, DEXAMETHASONE AND IXAZOMIB VS. POMALIDOMIDE AND DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA REFRACTORY TO LENALIDOMIDE AND PROTEASOME INHIBITOR-BASED THERAPY

This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with refractory multiple myeloma. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop tumor cells from growing. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.


Eligibility Criteria:

* Documentation of Disease: Histologically confirmed diagnosis of symptomatic multiple myeloma.

* Measurable disease:
- Serum M-protein ≥ 1.0 g/dL and/or
- Urine M-protein ≥ 200 mg/24 hours and/or
- Involved serum free light chain level ≥ 10 mg/dL and an abnormal serum free light chain ratio and/or
- Baseline marrow burden of myeloma of at least 30%

* Prior Treatment:
- Previously treated symptomatic multiple myeloma
- Lenalidomide and proteasome inhibitor-refractory multiple myeloma (dual refractory disease)
- At least 2 or more prior lines of systemic therapy for multiple myeloma
- Allogeneic stem cell transplantation is allowed provided the patient is ≥ 1 year from transplant, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, no evidence of active infection and meets all other criteria for participation.
- No other chemotherapy or radiation therapy within 14 days prior to registration
- No investigational agent within 21 days prior to registration
- Pomalidomide naïve and pomalidomide sensitive disease are allowed during phase I and phase II
- No concurrent investigational therapy
- No major surgery within 28 days prior to registration
Phase I/II
NCT02004275
Oncology
Hematologic
Alison Conlin, M.D.
Alliance
Laurie Delanty

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.