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

July 5, 2021 updated by: Grupo Cooperativo de Hemopatías Malignas
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Estado De México
      • Huixquilucan, Estado De México, Mexico, 52763
        • Grupo Cooperativo de Hemopatías Malignas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A - Non transplant
Carfilzomib Lenalidomide Daratumumab Dexamethasone
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

Other Names:
  • Lenalidomide
  • Dexamethasone
  • Carfilzomib
Active Comparator: Group B - transplant
Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)
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

Other Names:
  • Lenalidomide
  • Dexamethasone
  • Carfilzomib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response with negative minimal residual disease
Time Frame: 10 months
Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months
Overall survival measured on months on both study groups
36 months
Progression free survival
Time Frame: 36 months
Progression free survival measured on months from the time to the end of treatment to disease progression on both study groups
36 months
Rate of Adverse Events
Time Frame: 36 months
Rate of adverse events rated grade ≥3 by CTCAE 5.0
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Cooperativo de Hemopatías Malignas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAL 319/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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