OncoMatch/Clinical Trials/NCT06536413
ATRA and Carfilzomib in Plasma Cell Myeloma Patients
Is NCT06536413 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including All-Trans Retinoic Acid (ATRA) Dose 0 and All-Trans Retinoic Acid (ATRA) Dose -1 for multiple myeloma.
Treatment: All-Trans Retinoic Acid (ATRA) Dose 0 · All-Trans Retinoic Acid (ATRA) Dose -1 · All-Trans Retinoic Acid (ATRA) Dose 1 — This is a Phase IB/II trial that will investigate the safety, tolerability and efficacy of combination therapy using All-Trans Retinoic Acid (ATRA) with Carfilzomib based therapies in plasma cell myeloma also commonly referred as Multiple Myeloma (MM), in patients considered refractory to proteasome inhibitors (PIs). Multiple myeloma is an incurable clonal plasma cell disorder that comprises 10% of all hematologic malignancies. Over the past 30 years the global prevalence of multiple myeloma has risen to 126%, with 85% of diagnoses occurring in patients \>55 years of age. In the past 15 years, survival has improved considerably, which is attributed to the development of multiple different classes of medications, including proteasome inhibitors. Proteasome inhibitors are the foundation of many multiple myeloma treatments in both transplant eligible and ineligible patients for the past 2 decades. While proteasome inhibitors have improved both progression free survival (PFS) and overall survival (OS), many patients eventually develop disease progression arising from resistance to therapies. As a result, there is an unmet need to overcome resistance and find ways to enhance multiple myeloma sensitivity to proteasome inhibitor toxicity. Carfilzomib, a modified peptide epoxyketone that selectively targets intracellular proteasome enzymes, is approved in combination with dexamethasone in patients that have received ≥1 line of therapy or in combination. There are few studies assessing ways to enhance carfilzomib-mediated multiple myeloma toxicity. All-Trans Retinoic Acid (ATRA) is an oxidative metabolite of retinol (vitamin A) and plays an important role in the regulation of cellular proliferation and differentiation. In a recent pre-clinical study, ATRA was found to enhance sensitivity of carfilzomib-mediated apoptosis in vitro via an interferon beta (IFN-β) response pathway. In the clinical setting, ATRA is a well-tolerated drug that has shown little change in the rate of adverse events in early clinical trials with multiple myeloma. The investigators hypothesize that ATRA enhances sensitivity of multiple myeloma to carfilzomib therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunomodulatory drug
Previously treated with at least three lines of therapy which would include Immunomodulatory drugs (IMiDs)
Must have received: proteasome inhibitor (carfilzomib)
Proteosome inhibitors (including carfilzomib)
Must have received: anti-CD38 antibody
anti-CD 38 antibodies
Must have received: carfilzomib-based therapy (carfilzomib)
failed to achieve a minor response after completing at least 2 cycles of carfilzomib-based therapy or are relapsed while on therapy
Cannot have received: allogeneic hematopoietic cell transplantation
History of Allogeneic hematopoietic cell transplantation
Cannot have received: solid organ transplantation
History of ... solid organ transplantation
Cannot have received: proteasome inhibitor (carfilzomib, bortezomib, ixazomib)
Exception: previous allergic reaction or intolerance
Previous allergic reaction or intolerance to a proteasome inhibitor, including carfilzomib, bortezomib, or ixazomib
Cannot have received: investigational therapy
On investigational therapies within 12 weeks of enrollment
Lab requirements
Blood counts
Hemoglobin ≥8 g/dL (baseline or after Peripheral Red Blood Cell transfusion), Platelet count >75,000 and Absolute Neutrophil Count >1000/ micro liter
Kidney function
Creatinine Clearance ≥ 30 ml/min
Liver function
AST and ALT ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN
Cardiac function
Left Ventricular Ejection fraction ≥50%
Adequate organ function defined as: Hemoglobin ≥8 g/dL (baseline or after Peripheral Red Blood Cell transfusion), Platelet count >75,000 and Absolute Neutrophil Count >1000/ micro liter. Left Ventricular Ejection fraction ≥50%. Creatinine Clearance ≥ 30 ml/min. AST and ALT ≤ 3 × ULN. Total bilirubin ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Houston Methodist Neal Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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