To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
Age ≥ 18 years.
Subjects 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 by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level ≥ 5 g/L; or urinary M protein level ≥ 200 mg/24 hours; or serum immunoglobulin free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kap/lam light chain ratio.
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 defined as a <25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.
ECOG assessment of 0, 1, or 2.
Patient who currently participating or planning to participate in any interventional clinical study.
The investigator considers the patient unsuitable for participation in this study.
Non-secretory myeloma.
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.
Single group
All-trans Retinoic Acid in combination with the KPD Regimen
DrugRegimen: 1 course of treatment for 28 days until disease progression or intolerable toxicity occurs 1. ATRA mg/m2/day in 2 oral doses for 3 days. The first dose of ATRA will be given in the morning, two days prior to carfilzomib administration. The last ATRA dose will be given in the evening on the day of carfilzomib administration. 2. Proteasome inhibitor: Carfilzomib 27mg/m2 2 consecutive days per week x 3 weeks (20mg/m2 on day 1 and day 2 of cycle 1); 3. Pomalidomide 4mg orally daily, d1-21; 4. Dexamethasone given orally only on days 1, 8, 15, and 22 of each cycle; ≤75 years: 40 mg/day; \>75 years: 20 mg/day.
Overall response rate (ORR)
Defined as the proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria.
Complete response rate (CR)
Defined as the proportion of subjects whose serum and urine immunofixation electrophoresis are negative, and there is no soft tissue plasma cell tumor, with bone marrow plasma cells\<5% by the 2016 International Myeloma Working Group (IMWG) criteria.
Progression free survival (PFS)
PFS was defined as the time from the date of treatment initiation until the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.
Overall survival (OS)
OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
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