February 22, 2021 Hematology/Multiple Myeloma

Clinical Trial Information

Protocol – ECOG – EAA181

SCHEMA EAA181

Please Note – Below is a brief description of the eligibility, please contact the GHCI Research Department for full eligibility requirements.

Eligibility:

  1. Patient must be ≥ 18 years of age.
  2. Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain).
  3. Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria.
  4. Patients must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later.
  5. Patient must agree to register to the mandatory RevREMS program and be willing and able to comply with the requirements of RevREMS.
  6. Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator’s Brochure), or known sensitivity to mammalian-derived products. Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.

 



Clinical Trial Information

Protocol: EAA173

SCHEMA EAA173

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Age ≥ 18 years.
  2. Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is
    defined by any one of the following factors:
    • Abnormal serum free light chain ratio (≤ 0.125 or ≥ 8.0 and
    involved chain < 100 mg/L) by serum FLC assay
    • Serum M-protein level ≥ 3 gm/dL
    • Presence of t(4;14) or del 17p or 1q gain by conventional
    cytogenetics or FISH studies
  3. Bone marrow aspirate and/or biopsy is required to be performed within 28 days prior to randomization and must demonstrate 10-59%
    clonal plasma cells.
  4. Patients must have measureable disease as defined by having one or
    more of the following, obtained within 28 days prior to randomization:
    • ≥ 1 g/dL on serum protein electrophoresis AND  ≥ 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis
    NOTE: In the rare situation where the SPEP is felt to be unreliable,
    then quantitative immunoglobulin levels on nephelometry or
    turbidometry can be accepted. Please refer to Section 6.1.2
    for more information.
  5. SPEP, UPEP, and serum FLC are required to be performed within 28 days prior to randomization.
  6. Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above ULN).
  7. Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have
    contraindication to DVT prophylaxis/aspirin.
  8. Patients must not have more than one focal marrow lesion on MRI of either pelvis or spine.
  9. Concurrent use of erythropoietin is not allowed while on study therapy.

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