A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor. The APOLLO Study - The APOLLO Study

European Myeloma Network (EMN)0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Males and females at least 18 years of age.
•2. Voluntary written informed consent before performance of any study-related
•3. Subject must have measurable disease of MM as defined by the criteria below:
•IgG multiple myeloma: Serum M protein level >=1.0 g/dL or urine M-protein
•level >=200 mg/24 hours, or
•IgA, IgD, IgE, IgM multiple myeloma: Serum M-protein level >=0.5 g/dL or urine
•M-protein level >=200 mg/24 hours; or
•Light chain multiple myeloma, for subjects without measurable disease in the
•serum or urine: Serum immunoglobulin
•FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
•4. Subjects must have received prior anti-myeloma treatment. The prior
•treatment must have included both a PI- and
•lenalidomide-containing regimens. The subject must have had a response
•(ie, PR or better based on the investigator*s
•determination of response as defined by the modified IMWG criteria) to
•prior therapy.
•5. Subjects must have documented evidence of PD based on the investigator*s
•determination of response as defined by
•the modified IMWG criteria on or after the last regimen.
•6. Subjects who received only 1 line of prior treatment must have demonstrated
•PD on or within 60 days of completion of
•the lenalidomide containing regimen (ie, lenalidomide refractory).
•7. Eastern Cooperative Oncology Group (ECOG) performance status score of <=2.
•8. Willingness and ability to participate in study procedures.
•9. For subjects experiencing toxicities resulting from previous therapy, the
•toxicities must be resolved or stabilized to
•<=Grade 1.
•10. All of the following laboratory test results during Screening:
•a) Absolute neutrophil count >=1.0 × 109/L;
•b) Hemoglobin level >=7.5 g/dL (>=4.65 mmol/L) (transfusions are not permitted to
•reach this level);
•c) Platelet count >=75 × 109/L in subjects in whom <50% of bone marrow nucleated
•cells are plasma cells and platelet count
•>=50 x 109/L in subjects in whom >=50% of bone marrow nucleated cells are
•plasma cells (transfusions are not permitted
•to reach this level);
•d) Alanine aminotransferase (ALT) level <=2.5 times the upper limit of normal
•e) Aspartate aminotransferase (AST) level <=2.5 x ULN;
•f) Total bilirubin level <=1.5 x ULN, (except for Gilbert Syndrome: direct
•bilirubin <=1.5 × ULN);
•g) Creatinine clearance >=30 mL/min (Appendix 6);
•h) Serum calcium corrected for albumin <=14.0 mg/dL (<=3.5 mmol/L), or free
•ionized calcium <=6.5 mg/dL (<=1.6 mmol/L).
•11. Criterion (letter *g*) modified per Amendment 2:
•11.1 Reproductive Status
•a) Women of childbearing potential (WOCBP) must have 2 negative serum or urine
•pregnancy tests, one 10-14 days prior
•to start of study treatment and one within 24 hours prior to the start
•of study treatment. Females are not of reproductive
•potential if they have been in natural menopause for at least 24
另有 9 项未显示

排除标准

•1. Previous therapy with any anti-CD38 monoclonal antibody.
•2. Previous exposure to pomalidomide.
•3. Subject has received anti-myeloma treatment within 2 weeks or 5
•pharmacokinetic half-lives of the treatment, whichever is longer,
•before the date of randomization. The only exception is emergency use
•of a short course of corticosteroids (equivalent of
•dexamethasone 40 mg/day for a maximum of 4 days) for palliative
•treatment before Cycle 1, Day 1 (C1D1).
•4. Previous allogenic stem cell transplant; or autologous stem cell
•transplantation (ASCT) within 12 weeks before C1D1.
•5. History of malignancy (other than MM) within 3 years before the date of
•randomization (exceptions are squamous and basal cell
•carcinomas of the skin, carcinoma in situ of the cervix or breast, or
•other non-invasive lesion that in the opinion of the investigator,
•with concurrence with the Sponsor's medical monitor, is considered cured
•with minimal risk of recurrence within 3 years).
•6. Clinical signs of meningeal involvement of MM.
•7. 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. (Appendix 4).
•8. Clinically significant cardiac disease, including:
•a) Myocardial infarction within 6 months before C1D1, or unstable or
•uncontrolled condition (eg, unstable angina, congestive heart
•failure, New York Heart Association Class III-IV).
•b) Cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE]
•Grade 3 or higher) or clinically significant
•electrocardiogram (ECG) abnormalities.
•c) Electrocardiogram showing a baseline QT interval as corrected QTc >470 msec.
•9. Criterion modified per Amendment 2:
•9.1 Known:
•a) Active hepatitis A
•b) To be seropositive for hepatitis B (defined by a positive test for
•hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie,
•subjects who are positive
•for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies
•to hepatitis B surface antigen [antiHBs]) must be screened using real-time
•polymerase chain
•reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those
•who are PCR positive will be excluded. EXCEPTION: Subjects with serologic
•suggestive of HBV vaccination (antiHBs positivity as the only serologic
•marker) AND a known history of prior HBV vaccination, do not need to be tested
•DNA by PCR.
•c) To be seropositive for hepatitis C (except in the setting of a sustained
•virologic response, defined as aviremia at least 12 weeks after completion of
•antiviral therapy).10. Criterion Revised per Amendment 2
•10.1 Known to be seropositive for human immunodeficiency virus.
•11. Gastrointestinal disease that may significantly alter the absorption of
•pomalidomide.
另有 8 项未显示

研究者

发起方

European Myeloma Network (EMN)

相似试验

进行中（未招募）

1 期

Study to compare Pomalidomide and Dexamethasone With or Without Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.Relapsed or Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

EUCTR2017-001618-27-DEEuropean Myeloma Network (EMN)302

进行中（未招募）

1 期

Study to compare Pomalidomide and Dexamethasone With or Without Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.Relapsed or Refractory Multiple MyelomaMedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

EUCTR2017-001618-27-CZEuropean Myeloma Network (EMN)302

进行中（未招募）

1 期

EUCTR2017-001618-27-FREuropean Myeloma Network (EMN)302

进行中（未招募）

1 期

EUCTR2017-001618-27-NLEuropean Myeloma Network (EMN)302

进行中（未招募）

1 期

EUCTR2017-001618-27-ESEuropean Myeloma Network (EMN)302