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 (Jun 2026). This Phase 2 trial studies All-trans Retinoic Acid in combination with the KPD Regimen for multiple myeloma in relapse.
Treatment: All-trans Retinoic Acid in combination with the KPD Regimen — To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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.
Frequently asked questions
Is NCT06158412 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antimyeloma therapy, allogeneic stem cell transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages