Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged =70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)
- Conditions
- ewly diagnosed, symptomatic multiple myeloma in elderly patientsMedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004972-17-GR
- Lead Sponsor
- AGMT gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 198
• Age = 70 years
• Able to provide written informed consent in accordance with federal, local, and institutional guidelines
• Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization)
o Serum M protein =0.5 g/dL measured using serum protein immunoelectrophoresis
and/or
o Urine M protein =200 mg/24 hours measured using urine protein immunoelectrophoresis
and/or
o In subjects without detectable serum or urine M-protein, serum-free light chain (SFLC) =100 mg/L (involved light chain) and an abnormal FLC ratio
• No prior treatment for multiple myeloma
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
• Patients at cardiac risk (NYHA >ll) or pre-existing coronary heart disease, or any other clinically relevant cardiac complication) should be scheduled for a baseline ECHO and can only be included if the LVEF is >40%
• Adequate organ and bone marrow function within the 21 days prior to randomization defined by:
o Bilirubin < 2 times the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
o Absolute neutrophil count (ANC) = 750/mm3 (growth factor support for max 3 days allowed to achieve this value)
o Hemoglobin >8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
o Platelet count >50,000/mm3
o Calculated or measured creatinine clearance (CrCl) of =30 mL/min
Calculation should be based on the MDRD formula (age, gender, black/non- black, weight, height)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 198
• ECOG status >2
• Patients unlikely to tolerate Rd
• Waldenström macroglobulinemia
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia (> 2.0 x 109/L circulating plasma cells by standard differential)
• Myelodysplastic syndrome
• Smoldering Myeloma and MGUS
• Second malignancy within the past 5 years except:
o Adequately treated basal cell or squamous cell skin cancer
o Carcinoma in situ of the cervix
o Prostate cancer = Gleason score 6 with stable prostate-specific antigen (PSA over 12 months)
o Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
o Treated medullary or papillary thyroid cancer
• History of or current amyloidosis
• Glucocorticoid therapy within the 14 days prior to randomization that exceeds an accumulated dose of 160 mg dexamethasone or 1000 mg prednisone
• Extended field radio therapy (more than 3 fields) within the 21 days prior to randomization
• Contraindication to isatuximab, dexamethasone, lenalidomide or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
• Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 4 months prior to enrolment
• Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
• Uncontrolled hypertension or uncontrolled diabetes despite medication
• Significant neuropathy (Grade 2 with pain or Grade 3 or higher) within the 14 days prior to randomization
• Known cirrhosis
• Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
• Participation in another interventional study within the 28 days prior to randomization
• Major surgery (except kyphoplasty) within the 28 days prior to randomization
• Any other clinically significant medical disease or social condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method