Clinical trial NCT04288765: Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma
Official title: Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Newly diagnosed
Lead sponsor: Grupo Cooperativo de Hemopatías Malignas
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with newly diagnosed and previously untreated multiple myeloma living in Mexico that are fit for a quadruple therapy for multiple myeloma. Those patients that aren't fit or unavailable for transplant will go to the continuous treatment arm. The stratification of the study will be done by age and by cytogenetic risk.
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Complete response with negative minimal residual disease
timeFrame: 10 months
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Progression free survival
timeFrame: 36 months
measure: Rate of Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Huixquilucan
country: Mexico
facility: Grupo Cooperativo de Hemopatías Malignas
state: Estado De México
Study officials:
References: