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

NCT04288765 | Withdrawn Phase 3

• 1 other identifier: HAL 319/2019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Newly diagnosed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  36 months

• Progression free survival

  36 months

• Rate of Adverse Events

  36 months

Study Arms (2)

Group A - Non transplant

EXPERIMENTAL

Carfilzomib Lenalidomide Daratumumab Dexamethasone

Drug: Daratumumab Only Product in Parenteral Dose Form

Group B - transplant

ACTIVE COMPARATOR

Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)

Drug: Daratumumab Only Product in Parenteral Dose Form

Interventions

Daratumumab Only Product in Parenteral Dose Form 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

Also known as: Lenalidomide, Carfilzomib, Dexamethasone

Group A - Non transplant; Group B - transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age \> 18 years
• Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
• Capacity and willingness to provide a written informed consent.

You may not qualify if:

• POEMS syndrome
• Systemic amyloidosis
• Plasma cells leukemia
• Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
• 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.
• Non-controlled systematic active infection (viral, bacterial and/or fungic).
• Patients with known infection by human immunodeficiency virus (HIV).
• Active infection by hepatitis B.
• Active infection by hepatitis C.
• 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.
• 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.
• History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies.
• Pregnant or lactating women.

Sponsors & Collaborators

• Grupo Cooperativo de Hemopatías Malignas: lead

Study Sites (1)

Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, 52763, Mexico

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Injections; Lenalidomide; carfilzomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

ME (1)