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Research & Trial Information

SCHEMA

Protocol#: Alliance – A061202

Cancer Type:  Multiple Myeloma

Patient Eligibility:

  1. Histologically confirmed diagnosis of symptomatic multiple myeloma. Relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed.
  2. Patient must have measurable disease or non-measurable disease, defined as one or more of the following holding true:

    Measurable disease:

    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%

  3. Progression on lenalidomide as part of first line therapy (lenalidomide-refractory disease).
  4. Pomalidomide naïve disease.
  5. 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.
  6. 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).
  7. 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.
  8. No chemotherapy or radiation therapy within 14 days prior to registration.
  9. No investigational therapy within 14 days prior to registration.
  10. No major surgery within 28 days prior to registration.
  11. No G-CSF (Filgrastim) or GM-CSF (Sargramostim) within 7 days of registration or Pegfilgrastim within 14 days of registration to meet eligibility criteria.
  12. ≥18 years of age.
  13. ECOG Performance status 0-2.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Genesys Health System
Hurley Medical Center
Michigan Cancer Consortium

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