2024-518400-50-00招募中2 期
PRE-emptive DAratumumab Therapy Of minimal Residual disease reappearance or biochemical relapse in multiple myeloma (PREDATOR).
Polish Myeloma Consortium7 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2024年12月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 274
- 试验地点
- 7
- 主要终点
- To compare (EFS) between daratumumab arm and observation arm after randomization of patients with biochemical relapse of MM. To compare (EFS) between daratumumab arm and observation arm after randomization of patients with reappearance of MRD in MM.
研究概览
简要总结
PREDATOR-BR: To compare EFS between daratumumab arm and observation arm after randomization of patients with biochemical relapse of MM. EFS is defined as the time from randomization date to the date of development of new CRAB symptom(s), SPR or death from any cause. PREDATOR-MRD: To compare event-free survival (EFS) between daratumumab arm and observation arm after randomization of patients with reappearance of MRD in MM. EFS is defined as the time from randomization date to the date of development of new CRAB symptom(s), SPR or death from any cause.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •PREDATOR-BR: Patients with diagnosed symptomatic MM who have completed one or two prior lines of therapy; single or tandem autologous stem cell transplant is not considered a separate line of therapy and is not mandatory; and have achieved at least PR to last line of therapy, and who experience asymptomatic biochemical progression not meeting criteria for SPR.
- •Negative pregnancy test (serum βHCG) for women of childbearing potential (including pre-menopausal women who have had a tubal ligation) and for all women not meeting the definition of postmenopausal (≥ 24 months of amenorrhea), and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential.
- •FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the study.
- •PREDATOR-MRD: Patients with diagnosed symptomatic MM who have completed one or two prior lines of therapy; single or tandem autologous stem cell transplant is not considered a separate line of therapy and is not mandatory; and have achieved CR with negative MRD to the last line of therapy, and a. remain in CR MRD negative based on MRD flow cytometry assessment at screening (repeating MRD evaluation is not needed if CR MRD negative status in bone marrow sample using flow cytometry with sensitivity of at least 10-5 was confirmed not earlier than 3 months before inclusion to the study) or b. have CR with positive flow cytometry MRD status based on MRD flow cytometry assessment at screening. Those patients will be randomized directly after screening without entering MRD observation phase.
- •Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
- •Voluntary written informed consent.
- •Males and females ≥18 years of age.
- •Life expectancy of more than 3 months.
- •ECOG performance status of 0-
- •Adequate hepatic function, with bilirubin ≤1.5 x ULN and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
- •ANC ≥1.0 x 109/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 109/L.
- •Calculated creatinine clearance (by Cockroft-Gault) ≥50 mL/min (this equation is as follows: Creatinine clearance in ml/min: (140 – age) x body weight (kg) / 72 x plasma creatinine (mg/dL); multiplied by 0.85 for women) or serum creatinine below 2 g/dL.
排除标准
- •Potential subjects with evidence of progressive disease (CRAB symptoms) as per IMWG criteria.
- •CNS involvement.
- •Pregnant or lactating females.
- •Radiotherapy within 14 days before randomization. Seven days may be considered if to single area.
- •Major surgery within 3 weeks prior to first dose. Kyfoplasty is not considered as a major surgery.
- •Myocardial infarction within 3 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening.
- •Patient who in investigator’s opinion is unable to comply with the protocol requirements.
- •Uncontrolled hypertension or diabetes.
- •Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to enter the study.
- •Active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- •Patient with SPR - significant paraprotein relapse defined as doubling of the M-component in two consecutive measurements separated by < 2 months; or an increase in the absolute levels of serum M protein by 1g/dl, or urine M protein by 500mg /24h in two consecutive measurements separated by < 2 months, or involved serum FLC level by 20mg/dl (plus an abnormal FLC ratio) in two consecutive measurements separated by < 2 months.
- •Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone.
- •Any clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent.
- •Subject has received daratumumab or other anti-CD38 therapies previously.
- •Patients not able to tolerate daratumumab or required concomitant medication and procedures.
- •Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
- •Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study).
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •Plasma cell leukemia.
- •Waldenström’s macroglobulinemia.
结局指标
主要结局
To compare (EFS) between daratumumab arm and observation arm after randomization of patients with biochemical relapse of MM. To compare (EFS) between daratumumab arm and observation arm after randomization of patients with reappearance of MRD in MM.
To compare (EFS) between daratumumab arm and observation arm after randomization of patients with biochemical relapse of MM. To compare (EFS) between daratumumab arm and observation arm after randomization of patients with reappearance of MRD in MM.
次要结局
- SPR, CRAB or death. Overall response rate (ORR) as determined by Investigator evaluation, defined as the percentage of subjects achieving an objective response (i.e., partial response or better), using the IMWG Consensus Panel 1 response criteria.
研究者
President
Scientific
Polish Myeloma Consortium
研究点 (7)
Loading locations...
相似试验
招募中
3 期
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple MyelomaMultiple Myeloma2023-507632-20-00European Myeloma Network B.V.440
招募中
2 期
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaNCT07297563Institute of Hematology & Blood Diseases Hospital, China160
招募中
2 期
Daratumumab combined with Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting with Extramedullary Disease2024-514963-24-00European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale11
招募中
2 期
An open label, multicenter, Phase 2, pilot study, evaluating early treatment with bispecific T-cell redirectors (teclistamab and talquetamab) in the therapy of newly diagnosed high -risk multiple myelomaMultiple Myeloma2024-514016-26-00Fundacion Pethema30
招募中
3 期
A Study of combination of Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) compared to VELCADE, Lenalidomide, and Dexamethasone (VRd) in participants with Previously Untreated Multiple MyelomaMultiple Myeloma2023-506125-10-00European Myeloma Network Stichting, Emn Trial Office S.r.l. Impresa Sociale688