Carfilzomib Daratumumab Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    52
  • sponsor
    Grupo Cooperativo de Hemopatías Malignas
Updated on 19 February 2024
dexamethasone
renal failure
calcium
cell transplantation
anemia
multiple myeloma
lenalidomide
carfilzomib
daratumumab
bone marrow procedure
bone lesion
bone marrow plasma cells
autologous hematopoietic stem cell transplant

Summary

Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem cell transplantation versus patients with 8 cycles of KRDd without autologous stem cell transplantation.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age 18-65 years
Treatment Daratumumab Only Product in Parenteral Dose Form
Clinical Study IdentifierNCT04288765
SponsorGrupo Cooperativo de Hemopatías Malignas
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with newly diagnosed and previously untreated multiple myeloma by the International Myeloma Working Group criteria that requires treatment based on: Presence of elevated calcium, renal failure, anemia and/or bone lesions (CRAB) Clonal bone marrow plasma cells 60% Involved/uninvolved serum free light chain ratio 100 >1 focal lesions on MRI studies (5 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 Criteria

POEMS syndrome
Systemic amyloidosis
Plasma cells leukemia
Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
Improper liver function: total bilirubin > 1.5 x upper limit of normal (ULN) or > 3 x ULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartate aminotransferase (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 to screening, 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 basal or squamous cell carcinoma or "in situ" carcinoma of cervix or breast
History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies
Pregnant or lactating women
Clear my responses

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