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临床试验/EUCTR2021-000803-20-PL
EUCTR2021-000803-20-PL进行中（未招募）1 期

MAGNETISMM-6: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA

Pfizer Inc.0 个研究点目标入组 966 人开始时间: 2022年10月5日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
Pfizer Inc.
入组人数
966
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

性别
All

入选标准

  • •Participants must meet the following inclusion criteria to be eligible for enrollment into the study. Criteria are for both Part 1 and Part 2 unless otherwise specified:
  • •Age and Sex:
  • •1. Participant’s age =18 years (or the minimum country specific age of consent if >18) at Visit 1 (Screening).
  • •Male participants and female participants of childbearing potential must agree to use methods of contraception as described in Section 5.3.1.
  • •A female participant is eligible to participate if she is not pregnant or breastfeeding.
  • •Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
  • •Type of Participant and Disease Characteristics:
  • •2. Diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014), including measurable disease based on IMWG criteria as defined by at least 1 of the following (as assessed by the central laboratory for Part 2):
  • •o Serum M-protein =0.5 g/dL;
  • •o Urinary M-protein excretion =200 mg/24 hours;
  • •o Involved FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • •3. Part 1 only: Participant with NDMM or RRMM. NDMM participant must be transplant-ineligible as defined by age =65 years or transplantineligible as defined by age <65 years with comorbidities impacting the possibility of transplant. Participants with RRMM must have received 1-2 prior lines of MM therapy including at least one IMiD and one PI (See Appendix 17 of the protocol).
  • •Part 2 only: Participant has NDMM and is transplant-ineligible as defined by age =65 years or is transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
  • •4. ECOG performance status =2.
  • •5. BM function characterized by the following:
  • •a. ANC =1.0 × 109/L (use of G-CSFs is permitted if completed at least 7 days prior to planned start of dosing);
  • •b. Platelet count =75,000/µL if <50% of BM nucleated cells are plasma cells, or =50,000/µL if =50% of BM nucleated cells are plasma cells (transfusion support is permitted if completed at least 7 days prior to planned start of dosing); and
  • •c. Hemoglobin =8 g/dL (transfusion support is permitted if completed at least 14 days prior to planned start of dosing).
  • •NOTE: Hematologic parameters are also to be met on Day 1 prior to proceeding with study treatment administration.
  • •6. Corrected serum calcium =14 mg/dL (=3.5 mmol/L), or free ionized calcium =6.5 mg/dL (=1.6 mmol/L).
  • •7. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 11
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 955

排除标准

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions:
  • •1. Smoldering MM or MGUS or Waldenströms Macroglobulinemia or Plasma cell leukemia as defined as =20 % circulating plasma cells in the peripheral blood with an absolute plasma cell count of more than 2 × 109/L or Systemic light chain amyloidosis or POEMS Syndrome.
  • •2. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
  • •a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
  • •b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
  • •c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
  • •d. Prolonged QT syndrome (or QTcF >470 msec at screening).
  • •e. LVEF <40% as determined by a MUGA scan or ECHO.
  • •3. Ongoing Grade 3 or higher peripheral sensory or motor neuropathy, history of GBS or GBS variants, or history of any Grade >3 peripheral motor polyneuropathy.
  • •4. Participants with active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness. Active infections must be resolved at least 14 days prior to enrollment. Comments regarding specific circumstances follow.
  • •a. HIV: In equivocal cases, participants whose viral load is negative may be eligible. HIV seropositive participants who are otherwise healthy and at low risk for AIDS-related outcomes could be considered eligible. Potential eligibility for a specific HIV positive protocol candidate should be evaluated and discussed with the Sponsor prior to any screening, based on current and past CD4 and
  • •T-cell counts, history (if any) of AIDS defining conditions (eg, opportunistic infections), and status of HIV treatment. Also, the potential for drug-drug interactions will be taken into consideration.
  • •b. HBV/HCV: Relevant laboratory tests should be performed at screening. Refer to CDC website (https://www.cdc.gov/hepatitis/index.htm) for further details.
  • •This criterion excludes participants with a positive HbsAg (ie, either acute or chronic active hepatitis).
  • •However, participants with HBV antibody positivity indicating immunity, either due to vaccination or prior natural infection, are eligible.
  • •Participants with positive anti-HbcAb but negative HbsAg and anti-HbsAb profile are eligible if HBV DNA is not detected.
  • •Positive HCV antibody is indicative of infection but may not necessarily render a potential participant ineligible, depending on clinical circumstances. If exposure to HCV is recent, HCV antibody may not have yet turned positive. In this circumstance it is recommended to test HCV RNA. Refer to CDC website for further details (https://www.cdc.gov/hepatitis/hcv/pdfs/hcv_graph.pdf).
  • •5. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
  • •6. Participants with known or suspected hypersensitivity to the study interventions or any of their excipients.

研究者

发起方
Pfizer Inc.

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