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

NCT ID: NCT04288765

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2025-02-28

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A - Non transplant

Carfilzomib Lenalidomide Daratumumab Dexamethasone

Group Type: EXPERIMENTAL

Daratumumab Only Product in Parenteral Dose Form

Intervention Type: DRUG

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

Group B - transplant

Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)

Group Type: ACTIVE_COMPARATOR

Daratumumab Only Product in Parenteral Dose Form

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Lenalidomide; Carfilzomib; Dexamethasone

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Cooperativo de Hemopatías Malignas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, Mexico

Countries

Mexico

Other Identifiers

HAL 319/2019

Identifier Type: -

Identifier Source: org_study_id