ACTRN12621001530819进行中（未招募）2 期
ALLG MM24: A phase 2, open label, multicenter, single-stage study to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with amyloid light chain (AL) amyloidosis not in very good partial response (VGPR) or better after any previous therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Minimum age of 18 years
- •2.Histologic diagnosis of AL amyloidosis;
- •3.Patients should have received at least one line with an alkylating agent and/or a PI, and Dexamethasone and not be in VGPR (or better) at the time of inclusion (patients who did not reach VGPR before, or patients in VGPR or better before but with a hematological relapse at the time of inclusion can be included);
- •4.Measurable hematologic disease: difference between involved and uninvolved free light chain (FLC) > 50 mg/L with an abnormal k/l ratio;
- •5.Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system)
- •6.Wash-out period of at least 4 weeks from previous antitumor therapy or any investigational treatment or 5 half-lives from previous antibodies, whichever is longer.
- •7.Adequate bone marrow function prior to 1st drug intake (C1D1), without transfusion or growth factor support within 5 days prior to 1st drug intake, defined as:
- •-Absolute neutrophils count equals to 1000/mm3,
- •-Platelets equal to or greater than 75000/mm3,
- •-Hemoglobin equal to or greater than 8.0 g/dL,
- •8.Adequate organ function defined as:
- •-Serum ASAT or ALAT equal to or less than 3.0 X Upper Limit of the normal range (ULN),
- •-Serum total bilirubin level < 1.5 x ULN, unless for subjects with Gilbert’s syndrome where the direct bilirubin should then be equal to or less than 2.0 x ULN.
- •9.ECOG status equal to or less than 2
- •10.Male participants must agree to use contraception during the intervention period and for at least 5 months after the last dose of isatuximab/dexamethasone and refrain from donating sperm during this period.
- •11. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
排除标准
- •1. AL amyloidosis with isolated soft tissue involvement
- •2. Bone marrow plasma cells >30% and clinically symptomatic multiple myeloma with lytic bone lesions
- •3. NT-proBNP > 8500 ng/L and hs-troponin I > 100 ng/L or hs- troponin T > 50 ng/L (cardiac stage IIIb patients)
- •4. Repetitive ventricular arrhythmias on 24h Holter ECG despite anti-arrhythmic treatment sustained ventricular tachycardia, aborted ventricular fibrillation, atrioventricular nodal or sinoatrial nodal dysfunction with no pacemaker
- •5. Chronic atrial fibrillation with uncontrolled heart rate
- •6. Significant cardiac dysfunction; myocardial infarction within 12 months; unstable poorly controlled angina pectoris
- •7. Uncorrected valvular disease unrelated to AL amyloid cardiomyopathy
- •8. QT interval as corrected by Fridericia’s formula > 550 msec without pacemaker,
- •9. Undergoing dialysis
- •10. Ongoing toxicity (excluding alopecia and those listed in eligibility criteria) from any prior therapy > G1 (NCI-CTCAE v5.0)
- •11. Supine systolic blood pressure < 90 mmHg, or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of < 80 mmHg despite medical management (i.e. midodrine, fludrocortisones) in the absence of volume depletion
- •12. Previous anti-CD38 therapy or Pomalidomide therapy (if refractory to Pomalidomide)
- •13. Hypersensitivity to IMiD® defined as any hypersensitivity reaction leading to stop IMiD® within the 2 first cycles or toxicity, which does meet intolerance definition
- •14. Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, polysorbate 80, poloxamer 188, sucrose or any of the other components of study treatment that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents
- •15. History of malignancy (other than AL amyloidosis) within 3 years before the date of inclusion
- •16. Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results
- •17. Active systemic infection and severe infections requiring treatment with a parenteral administration of antibiotics
- •18. Received any investigational drug within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention, whichever is longer. In case of very aggressive disease (i.e acute leukemia) delay could be shortened after agreement between sponsor and investigator, in absence of residual toxicities from previous therapy
- •19. Known positive for HIV or active hepatitis A, B or C:
- •Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA
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