A Phase II Study of Isatuximab for Patients with Previously Treated AL Amyloidosis

Research & Trial Information


Protocol #: S1702

Cancer Type: Hematology AL


  1. Patient must have relapsed or refractory primary systemic AL Amyloidosis, histologically-confirmed by positive Congo red stain with green by birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence).
  2. Patient must have measurable disease. Serum β2 microglobulin, Serum Quantitative Immunoglobulins (IgG, IgA, and IgM), serum free kappa and lambda, and SPEP with M-protein quantification must be obtained within 14 days prior to registration.
  3.  Patient must demonstrate a difference in the involved serum free light chains (kappa or lambda) versus the uninvolved serum free light chain of ≥ 4.5mg/dL within 14 days prior to registration.
  4. Patient must have objective organ involvement.
  5. Patients must not have active symptomatic multiple myeloma.
  6. Patient must be relapsed or refractory to at least one prior line of therapy (such as: transplant, radiation, or chemotherapy).
  7. Patients must have completed other systemic therapy ≥ 14 days or investigational drug ≥ 28 days prior to registration, surgery (other than biopsies) ≥ 21 days prior to registration, and any autologous stem cell transplant (ASCT) ≥ 100 days prior to registration.
  8. Patients must not have received any or supplements which have been known to have some anti-amyoidogenic effect (such as: doxycycline; curcuramin; prednisone; dexamethasone; EGCG) within 14 days prior to registration.
  9. Patients must not have any known allergies to isatuximab or other monoclonal antibody therapies.
  10. Patients must not have received daratumumab within 56 days prior to registration nor have been refractory to daratumumab.
  11. Patients must not be eligible for autologous stem cell transplantation.
  12. Patients must be ≥ 18 years of age.
  13. Patients must have bone marrow aspirate, including FISH (including: del 17p; t11;14; t4;14, t14;16; and del 13q) and cytogenetic testing (normal – XY; and all abnormalities) within 35 days prior to registration.
  14. Patients must have adequate cardiac function.
  15. Patients must have a Zubrod Performance Status ≤ 2.
  16. Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled, active infection requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus.
  17. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years.


Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

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Genesys Health System
Hurley Medical Center
Michigan Cancer Consortium


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