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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04288765
• Other study ID #: HAL 319/2019
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 1, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: July 2021
• Source: Grupo Cooperativo de Hemopatías Malignas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Daratumumab Only Product in Parenteral Dose Form
Induction = 8 cycles Carfilzomib on Day 1st, 8th and 15th Lenalidomide: Day 1 to 21 Daratumumab: Cycles 1-2: weekly Cycles 3-4: every two weeks Cycles 5-8: every month Dexamethasone: 40 mg weekly

Locations

Country	Name	City	State
Mexico	Grupo Cooperativo de Hemopatías Malignas	Huixquilucan	Estado De México

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Cooperativo de Hemopatías Malignas

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response with negative minimal residual disease	Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria	10 months
Secondary	Overall survival	Overall survival measured on months on both study groups	36 months
Secondary	Progression free survival	Progression free survival measured on months from the time to the end of treatment to disease progression on both study groups	36 months
Secondary	Rate of Adverse Events	Rate of adverse events rated grade =3 by CTCAE 5.0	36 months