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OncoMatch/Clinical Trials/NCT06158412

All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma

Is NCT06158412 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies All-trans Retinoic Acid in combination with the KPD Regimen for multiple myeloma in relapse.

Phase 2RecruitingThe First Affiliated Hospital of Xiamen UniversityNCT06158412Data as of May 2026

Treatment: All-trans Retinoic Acid in combination with the KPD RegimenTo investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: antimyeloma therapy

Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. Refractory disease is defined as a <25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.

Cannot have received: antimyeloma therapy

Subjects have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes subjects who received a cumulative dose of corticosteroids greater than or equal to a 140 mg prednisone equivalent dose or a single dose of corticosteroids greater than or equal to a 40 mg/day dexamethasone equivalent dose within 2 weeks prior to initiation of treatment.

Cannot have received: allogeneic stem cell transplant

Exception: allowed if >1 year prior to enrollment and no immunosuppressive medications within 1 month prior

Subjects 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.

Lab requirements

Blood counts

platelet count <30 x 10^9/L or absolute neutrophil count <1.0 x 10^9/L

Kidney function

Creatinine clearance <20 mL/min

Liver function

Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma

Cardiac function

Myocardial infarction within 6 months prior to Day 1 of Cycle 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure, New York Heart Association Class III-IV); Cardiac arrhythmia (CTCAE grade 2 or higher) or clinically significant ECG abnormalities; Screening 12-lead ECG showing a baseline QT interval (QTcF) >470 ms

Inadequate bone marrow reserve as defined by a platelet count <30 x 10^9/L or absolute neutrophil count <1.0 x 10^9/L. Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma. Creatinine clearance <20 mL/min. Cardiac disease, including myocardial infarction within 6 months, unstable angina, congestive heart failure (NYHA III-IV), arrhythmia (CTCAE grade 2 or higher), or QTcF >470 ms.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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