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

STATUS

Recruiting
days left to enroll

69
participants needed

52
sponsor

Grupo Cooperativo de Hemopatías Malignas

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Updated on 19 February 2024

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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	18years - 65years
Treatment	Daratumumab Only Product in Parenteral Dose Form
Clinical Study Identifier	NCT04288765
Sponsor	Grupo Cooperativo de Hemopatías Malignas
Last Modified on	19 February 2024

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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

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