CompletedPhase 1/2

Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis

United States28 participantsStarted 2017-06-12

Plain-language summary

Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced in your bone marrow and cannot be broken down. It builds up in different organs preventing them from working well. The most commonly affected organs are the kidneys, heart, liver, spleen, nervous system, and digestive tract. Treatment with chemotherapy can stop the growth of abnormal cells that produce this abnormal protein. Decrease in amyloid protein in the body improves the function of the affected organs. The primary purpose of this study is to determine the safest dose of the medications and how well you tolerate them or the "maximum tolerated dose" (MTD). The study uses Ixazomib in combination with cyclophosphamide and dexamethasone to treat people with newly diagnosed AL amyloidosis. This combination of medications is an oral regimen that is taken over 6 cycles. The first part of study will determine the safety of this regimen and the second part of the study will determine how effective this combination of drugs is to treat your disease.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female patients 18 years or older. * Biopsy-proven diagnosis of AL amyloidosis according to the following standard criteria: * Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence * If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary * Measurable disease defined by serum differential free light chain concentration (difference between amyloid forming \[involved\] and non amyloid forming \[uninvolved\] free light chain \[FLC\]) ≥ 50 mg/L). * Amyloid organ involvement including renal, cardiac, GI and/or nervous system involvement as well as soft tissue disease * Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2. * Patients must meet the following clinical laboratory criteria: * Absolute neutrophil count (ANC) ≥1,000/mm3 and platelet count ≥75,000/mm3. * Hemoglobin ≥ 8.0 g/dL * Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. * Total bilirubin ≤ 2 the upper limit of the normal range (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 x ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 ULN. * Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault Formula). Exclusion Crite…

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: up to 3 years

Trial details

NCT IDNCT03236792

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-20