Can vitamin a make a failed myeloma drug effective again?
NCT ID NCT06536413
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a vitamin A derivative (ATRA) to a standard drug combination (carfilzomib and dexamethasone) can overcome resistance in multiple myeloma patients whose cancer no longer responds to carfilzomib. About 42 adults with relapsed/refractory myeloma will receive ATRA alongside their carfilzomib-based therapy. The goal is to see if the combination is safe and can shrink tumors or slow disease progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- All-Trans Retinoic Acid (ATRA) combined with carfilzomib and dexamethasone
- What this could lead to
- If it works, this could offer a new treatment option for multiple myeloma patients whose cancer has become resistant to carfilzomib, potentially extending remission.
- What could go wrong
- This is an early-phase trial with only 42 participants, so results may not apply broadly. ATRA may not restore sensitivity in all patients, and side effects from the combination are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
Jul 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years with relapsed/refractory multiple myeloma documented according to International Myeloma Working Group (IMWG) criteria. 2. 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 after completing at least 2 cycles of carfilzomib-based therapy or are relapsed while on therapy. 3. Patient or legal guardian voluntarily can sign informed consent. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 5. Adequate organ function defined as: 1. Hemoglobin ≥8 g/dL (baseline or after Peripheral Red Blood Cell transfusion), Platelet count \>75,000 and Absolute Neutrophil Count \>1000/ micro liter. 2. Left Ventricular Ejection fraction ≥50% 3. Creatinine Clearance ≥ 30 ml/min 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) 5. Total bilirubin ≤ 1.5 × ULN 6. Measurable disease requiring treatment defined as patients having one or more of the criteria below: 1. Serum M protein ≥ 0.5 g/dL or 2. Urine M-protein ≥ 200 mg/24 hours or 3. Serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum 4. kappa lambda ratio. 7. 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. 8. Willingness to undergo interim bone marrow biopsy as scheduled or if felt to be medically indicated. 9. Life Expectancy ≥ 6 months 10. Women with childbearing potential and men should practice at least one of the following methods of birth control: 1. Total abstinence from sexual intercourse (periodic abstinence not acceptable); 2. Surgically sterile partner(s) including vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; 3. Intrauterine device with an additional method of contraception to make two effective methods of contraception during treatment with Vesanoid; 4. Double-barrier method (condom + diaphragm or cervical cap with spermicide, contraceptive sponge, jellies, or cream); 5. 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 at least 3 months prior to study drug administration. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study Women of child-bearing potential must have a negative results of a pregnancy test performed at initial screening on a serum sample obtained within 21 days prior to C1D1, and prior to dosing on a urine sample obtained within 72 hours of the first study drug administration. Males must refrain from sperm donations from date of C1D1 to 90 days after the last date of the study drug. Exclusion Criteria: 1. 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. 2. Plasma Cell Leukemia (Previously treated Plasma Cell Leukemia can be included per PI discretion) 3. Concurrent light chain amyloidosis 4. 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 while on ATRA). 5. Pregnant or breast feeding 6. Severe, active, recurrent, or intercurrent infection (viral, bacterial, fungal), or diagnosis of neutropenia and fever within one week of C1D1. 7. History of Allogeneic hematopoietic cell transplantation or solid organ transplantation. 8. 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 anginal pain. 9. Patient has a significant history of renal, neurologic (peripheral neuropathy), psychiatric, endocrinologic (diabetes mellitus), metabolic, immunologic, cardiovascular, pulmonary, hepatic disease, or significant social situation within the past 6 months that, in the opinion of the investigator, would impede his/her ability to fully participate in the study. For patients who have required an intervention for the above diseases within the past 6 months, a case-by-case discussion with the investigator must occur. 10. On investigational therapies within 12 weeks of enrollment. 11. Previous allergic reaction or intolerance to a proteasome inhibitor, including carfilzomib, bortezomib, or ixazomib. 12. Or deemed unfit for the study on evaluation by Investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Houston Methodist Neal Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?