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

Sponsored by Grupo Cooperativo de Hemopatías Malignas

About this trial

Last updated 5 years ago

Study ID

HAL 319/2019

Status

Withdrawn

Type

Interventional

Phase

Phase 3

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Ended a year ago

What is this trial 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.

What are the participation requirements?

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.