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New treatment option for Multiple Myeloma in Relapse
Official title All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma
ClinicalTrials.gov ID: NCT06158412
What this study is testing
What is All-trans Retinoic Acid in combination with the KPD Regimen?
All-trans Retinoic Acid in combination with the KPD Regimen is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for multiple myeloma in relapse.
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
- To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
- 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.
- people must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients...
- Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior...
- ECOG assessment of 0, 1, or 2.
- Life expectancy of at least 3 months.
You likely can't join if
- Patient who currently participating or planning to participate in any treatment clinical study.
- The investigator considers the patient unsuitable for participation in this study.
- Non-secretory myeloma.
- people have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This...
- people who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used...
- Inadequate bone marrow reserve as defined by a platelet count \<30 x 109/L or absolute neutrophil count \<1.0 x 109/L.
See the full eligibility criteria
- Age ≥ 18 years.
- people must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients at some point in time when the presence of plasmacytoma is confirmed...
- Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is...
- ECOG assessment of 0, 1, or 2.
- Life expectancy of at least 3 months.
- The patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF).
- Patient who currently participating or planning to participate in any treatment clinical study.
- The investigator considers the patient unsuitable for participation in this study.
- Non-secretory myeloma.
- people have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes people who received a cumulative dose of corticosteroids...
- people who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used immunosuppressive medications within 1 month prior to the date of enrollment.
- Inadequate bone marrow reserve as defined by a platelet count \<30 x 109/L or absolute neutrophil count \<1.0 x 109/L.
- Subject has clinically significant lung disease, including: (1) Subject has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal. Please note that...
- people with clinically significant cardiac disease, including (1) Myocardial infarction within 6 months prior to Day 1 of Cycle 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function...
- Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma.
- Creatinine clearance \<20 mL/min.
- Known allergy to components of the test product, or severe allergy or hypersensitivity to humanized products.
- The subject has a concurrent serious and/or uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, infections, hypertension, etc.) that may interfere with the study procedures or results or that, in the...
- people known to be seropositive for human immunodeficiency virus (HIV) or have active hepatitis B or C.
- History of active malignancy within the past 5 years, except squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or cured within 5 years with minimal risk of recurrence in the opinion of...
- people known or suspected of not being able to comply with the study protocol (e.g. due to alcoholism, drug dependence, or psychological disorders), or the subject has any condition that, in the investigator's belief...
- Pregnant or lactating females.
- Peripheral neuritis ≥ grade 3.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
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 Xiamen, Fujian, China. 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.