Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease (NCT04984330) | Clinical Trial Compass
WithdrawnEarly Phase 1
Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease
Stopped: Funding withdrawn
United States0Started 2021-12
Plain-language summary
The purpose of this study is to test the safety and efficacy of Selinexor and Dexamethasone and see what effects it has on AL amyloidosis.
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:
* Diagnosis of primary AL amyloidosis
* Relapsed and/or refractory AL amyloidosis
* Measurable disease
* Male or female patients 18 years or older
* Able to give voluntary written consent
* Eastern Cooperative Oncology Group performance status and/or other performance status 0, 1, or 2.
* Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3.
* Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
* Calculated creatinine clearance ≥ 30 mL/min
Exclusion Criteria:
* Non-AL amyloidosis
* Clinically overt myeloma
* Prior exposure to Selinexor
* Clinically significant cardiac disease
* Severe obstructive airway disease
* Female patients who are lactating or have a positive serum pregnancy test during the screening period
* Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment
* Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
* Major surgery within 14 days before enrollment.
* Radiotherapy within 14 days before enrollment.
* Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, …
What they're measuring
1
Compare number of dose limiting toxicity (DLT) occurence to measure safety and toxicity
Timeframe: approximately 12 months
Trial details
NCT IDNCT04984330
SponsorWeill Medical College of Cornell University