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

Grupo Cooperativo de Hemopatías Malignas

Status and phase: Withdrawn; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Daratumumab Only Product in Parenteral Dose Form

Study type: Interventional

Funder types: Other

Identifiers

NCT04288765

HAL 319/2019

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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 ³ 60% Involved/uninvolved serum free light chain ratio ³ 100 >1 focal lesions on MRI studies (³5 mm in size)
2. Age > 18 years
3. Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
4. Capacity and willingness to provide a written informed consent.

Exclusion criteria

1. POEMS syndrome
2. Systemic amyloidosis
3. Plasma cells leukemia
4. Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
5. 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.
6. Non-controlled systematic active infection (viral, bacterial and/or fungic).
7. Patients with known infection by human immunodeficiency virus (HIV).
8. Active infection by hepatitis B.
9. Active infection by hepatitis C.
10. 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.
11. 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.
12. History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies.
13. Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group A - Non transplant

Experimental group

Description:

Carfilzomib Lenalidomide Daratumumab Dexamethasone

Treatment:

Drug: Daratumumab Only Product in Parenteral Dose Form

Group B - transplant

Active Comparator group

Description:

Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)

Treatment:

Drug: Daratumumab Only Product in Parenteral Dose Form