Research & Trial Information
Protocol#: Alliance – A061202
Cancer Type: Multiple Myeloma
- Histologically confirmed diagnosis of symptomatic multiple myeloma. Relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed.
- Patient must have measurable disease or non-measurable disease, defined as one or more of the following holding true:
• Serum M-protein ≥0.5 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
For non-measurable disease:
• Baseline marrow burden of myeloma of at least 30%
- Progression on lenalidomide as part of first line therapy (lenalidomide-refractory disease).
- Pomalidomide naïve disease.
- Proteasome inhibitor naïve or sensitive disease. Proteasome inhibitor sensitive disease is defined as a PR or better to prior proteasome inhibitor-based therapy that is maintained for ≥ 60 days from the last dose of the proteasome inhibitor.
- 1 prior line of systemic therapy for multiple myeloma, where a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy). A new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression or relapse (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen). A new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy).
- Allogeneic stem cell transplantation is allowed provided the patient is ≥ 1 year from transplant at time of registration, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, and no evidence of active infection.
- No chemotherapy or radiation therapy within 14 days prior to registration.
- No investigational therapy within 14 days prior to registration.
- No major surgery within 28 days prior to registration.
- No G-CSF (Filgrastim) or GM-CSF (Sargramostim) within 7 days of registration or Pegfilgrastim within 14 days of registration to meet eligibility criteria.
- ≥18 years of age.
- ECOG Performance status 0-2.