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Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436029
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Study Description
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Brief Summary:
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.

Condition or disease Intervention/treatment Phase
Myeloma Multiple Biological: Descartes 11 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Descartes 11 Biological: Descartes 11
Car T-cells


Outcome Measures
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Primary Outcome Measures :
  1. Rate of stringent complete response [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be 18 years of age or older at the time of enrollment
  • High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).

Exclusion Criteria:

  • Patients who are pregnant or lactating.
  • Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436029


Contacts
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Contact: Adam S Chowdhury, MD 3013488698 adam.chowdhury@cartesiantx.com

Locations
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United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Investigator         
Principal Investigator: Ralph Boccia, MD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53226
Contact: Investigator         
Principal Investigator: Binod Dhakal, MD         
Sponsors and Collaborators
Cartesian Therapeutics
More Information
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT04436029    
Other Study ID Numbers: DC 11B
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases