Research & Trial Information
Protocol #: S1702
Cancer Type: Hematology AL
- 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).
- 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.
- 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.
- Patient must have objective organ involvement.
- Patients must not have active symptomatic multiple myeloma.
- Patient must be relapsed or refractory to at least one prior line of therapy (such as: transplant, radiation, or chemotherapy).
- 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.
- 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.
- Patients must not have any known allergies to isatuximab or other monoclonal antibody therapies.
- Patients must not have received daratumumab within 56 days prior to registration nor have been refractory to daratumumab.
- Patients must not be eligible for autologous stem cell transplantation.
- Patients must be ≥ 18 years of age.
- 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.
- Patients must have adequate cardiac function.
- Patients must have a Zubrod Performance Status ≤ 2.
- 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.
- 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.