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

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/A

Clinical Study ID

NCT04288765
HAL 319/2019
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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)
  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

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 oftreatment (1 week if it is one region)
  5. 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.
  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 toscreening, 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 basalor squamous cell carcinoma or "in situ" carcinoma of cervix or breast.
  12. History of allergic reaction or severe anaphylaxis to humanized or murine monoclonalantibodies.
  13. 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
    Mexico

    Site Not Available

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