Last updated: July 5, 2021
Sponsor: Grupo Cooperativo de Hemopatías Malignas
Overall Status: Trial Not Available
Phase
3
Condition
Multiple Myeloma
Lymphoproliferative Disorders
Cancer
Treatment
N/AClinical Study ID
NCT04288765
HAL 319/2019
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with newly diagnosed and previously untreated multiple myeloma by theInternational Myeloma Working Group criteria that requires treatment based on:Presence of elevated calcium, renal failure, anemia and/or bone lesions (CRAB) Clonalbone marrow plasma cells ³ 60% Involved/uninvolved serum free light chain ratio ³ 100 >1 focal lesions on MRI studies (³5 mm in size)
- Age > 18 years
- Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG)scale.
- Capacity and willingness to provide a written informed consent.
Exclusion
Exclusion Criteria:
- POEMS syndrome
- Systemic amyloidosis
- Plasma cells leukemia
- Radiotherapy on multiple sites on the period of 4 weeks before the initiation oftreatment (1 week if it is one region)
- Improper liver function: total bilirubin > 1.5 x upper limit of normal (ULN) or > 3 xULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartateaminotransferase (AST) > 3.0 x ULN.
- Non-controlled systematic active infection (viral, bacterial and/or fungic).
- Patients with known infection by human immunodeficiency virus (HIV).
- Active infection by hepatitis B.
- Active infection by hepatitis C.
- Significant cardiovascular diseases as uncontrolled or symptomatic arrhythmias,congestive heart failure or acute myocardial infarction within 2 months prior toscreening, or any New York Heart Association (NYHA) class 3 or 4 heart disease.
- Diagnosis of previous malignancies for 2 years, with exception of patients with basalor squamous cell carcinoma or "in situ" carcinoma of cervix or breast.
- History of allergic reaction or severe anaphylaxis to humanized or murine monoclonalantibodies.
- Pregnant or lactating women.
Study Design
Study Start date:
March 01, 2020
Estimated Completion Date:
February 28, 2025
Connect with a study center
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, Estado De México 52763
MexicoSite Not Available
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