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New treatment option for Multiple Myeloma
Official title ATRA and Carfilzomib in Plasma Cell Myeloma Patients
ClinicalTrials.gov ID: NCT06536413
What this study is testing
What is All-Trans Retinoic Acid (ATRA) Dose 0?
All-Trans Retinoic Acid (ATRA) Dose 0 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years with relapsed/refractory multiple myeloma documented according to International Myeloma Working Group (IMWG) criteria.
- Previously treated with at least three lines of therapy which would include Immunomodulatory drugs (IMiDs), Proteosome inhibitors (including...
- Patient or legal guardian voluntarily can sign informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
- Adequate organ function defined as:
You likely can't join if
- Non-secretory or hyposecretory multiple myeloma, defined as \<0.5 g/dL M-protein in serum, \<200 mg/24-hour urine M-protein, or disease only measured...
- Plasma Cell Leukemia (Previously treated Plasma Cell Leukemia can be included per PI discretion)
- Concurrent light chain amyloidosis
- Central nervous system involvement (patients with known brain metastases have poor prognosis and often develop progressive neurologic dysfunction...
- Pregnant or breast feeding
- Severe, active, recurrent, or intercurrent infection (viral, bacterial, fungal), or diagnosis of neutropenia and fever within one week of C1D1.
See the full eligibility criteria
- Age ≥ 18 years with relapsed/refractory multiple myeloma documented according to International Myeloma Working Group (IMWG) criteria.
- Previously treated with at least three lines of therapy which would include Immunomodulatory drugs (IMiDs), Proteosome inhibitors (including carfilzomib), anti-CD 38 antibodies and failed to achieve a minor response...
- Patient or legal guardian voluntarily can sign informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
- 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
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN
- Measurable disease requiring treatment defined as patients having one or more of the criteria below:
- Serum M protein ≥ 0.5 g/dL or
- Urine M-protein ≥ 200 mg/24 hours or
- Serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum
- kappa lambda ratio.
- If previous autologous stem cell transplantation, must have fully recovered from transplant related toxicities and be \>60 days from transplant and have had hematologic recovery independent of growth factor support.
- Willingness to undergo interim bone marrow biopsy as scheduled or if felt to be medically indicated.
- Life Expectancy ≥ 6 months
- Women with childbearing potential and men should practice at least one of the following methods of birth control:
- Total abstinence from sexual intercourse (periodic abstinence not acceptable);
- Surgically sterile partner(s) including vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;
- Intrauterine device with an additional method of contraception to make two effective methods of contraception during treatment with Vesanoid;
- Double-barrier method (condom + diaphragm or cervical cap with spermicide, contraceptive sponge, jellies, or cream);
- Hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) for at least 3 months prior to study drug administration. If hormonal contraceptives are used, the specific contraceptive must have been used for...
- Non-secretory or hyposecretory multiple myeloma, defined as \<0.5 g/dL M-protein in serum, \<200 mg/24-hour urine M-protein, or disease only measured by serum free light chain.
- Plasma Cell Leukemia (Previously treated Plasma Cell Leukemia can be included per PI discretion)
- Concurrent light chain amyloidosis
- Central nervous system involvement (patients with known brain metastases have poor prognosis and often develop progressive neurologic dysfunction that may confound the evaluation of neurologic and other Adverse Events...
- Pregnant or breast feeding
- Severe, active, recurrent, or intercurrent infection (viral, bacterial, fungal), or diagnosis of neutropenia and fever within one week of C1D1.
- History of Allogeneic hematopoietic cell transplantation or solid organ transplantation.
- Unstable angina pectoris, cardiac arrhythmia or \> New York Heart Failure association class II cardiac failure, defined as comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or...
- Patient has a significant history of renal, neurologic (peripheral neuropathy), psychiatric, endocrinologic (diabetes mellitus), metabolic, immunologic, cardiovascular, pulmonary, hepatic disease, or significant social...
- On investigational therapies within 12 weeks of enrollment.
- Previous allergic reaction or intolerance to a proteasome inhibitor, including carfilzomib, bortezomib, or ixazomib.
- Or deemed unfit for the study on evaluation by Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.