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

Primary Purpose

Multiple Myeloma

Status

Withdrawn

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Daratumumab Only Product in Parenteral Dose Form

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Newly diagnosed

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Grupo Cooperativo de Hemopatías Malignas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A - Non transplant

Group B - transplant

Arm Description

Carfilzomib Lenalidomide Daratumumab Dexamethasone

Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)

Outcomes

Primary Outcome Measures

Complete response with negative minimal residual disease

Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria

Secondary Outcome Measures

Overall survival

Overall survival measured on months on both study groups

Progression free survival

Progression free survival measured on months from the time to the end of treatment to disease progression on both study groups

Rate of Adverse Events

Rate of adverse events rated grade ≥3 by CTCAE 5.0

Full Information

NCT ID

NCT04288765

First Posted

February 26, 2020

Last Updated

July 5, 2021

Sponsor

Grupo Cooperativo de Hemopatías Malignas

1. Study Identification

Unique Protocol Identification Number

NCT04288765

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Withdrawn

Why Stopped

incomplete recruitment

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Grupo Cooperativo de Hemopatías Malignas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Newly diagnosed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A - Non transplant

Arm Type

Experimental

Arm Description

Carfilzomib Lenalidomide Daratumumab Dexamethasone

Arm Title

Group B - transplant

Arm Type

Active Comparator

Arm Description

Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)

Intervention Type

Drug

Intervention Name(s)

Daratumumab Only Product in Parenteral Dose Form

Other Intervention Name(s)

Lenalidomide, Carfilzomib, Dexamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete response with negative minimal residual disease

Description

Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria

Time Frame

10 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival measured on months on both study groups

Time Frame

36 months

Title

Progression free survival

Description

Progression free survival measured on months from the time to the end of treatment to disease progression on both study groups

Time Frame

36 months

Title

Rate of Adverse Events

Description

Rate of adverse events rated grade ≥3 by CTCAE 5.0

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Grupo Cooperativo de Hemopatías Malignas

City

Huixquilucan

State/Province

Estado De México

ZIP/Postal Code

52763

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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