Back to resultsDescartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Primary Purpose
Myeloma Multiple
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Descartes 08
Sponsored by
About this trial
This is an interventional treatment trial for Myeloma Multiple
Eligibility 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.
Sites / Locations
- University of California IrvineRecruiting
- Sarah Cannon Research Institute at Tennessee OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Descartes 08
Arm Description
Outcomes
Primary Outcome Measures
Rate of stringent complete response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04816526
Brief Title
Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Official Title
Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 25, 2023 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cartesian Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma Multiple
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Descartes 08
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Descartes 08
Intervention Description
Car T-cells
Primary Outcome Measure Information:
Title
Rate of stringent complete response
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Chowdhury, MD, MBA
Phone
3013488698
Email
adam.chowdhury@cartesiantx.com
Facility Information:
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UCI Study team
Phone
1-877-UC -STUDY
Email
ucstudy@uci.edu
First Name & Middle Initial & Last Name & Degree
Stefan Ciurea, MD
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Ladd
Phone
615-524-4133
Email
Sarah.Ladd@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Jesus G Berdeja, MD
12. IPD Sharing Statement
Learn more about this trial
Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
We'll reach out to this number within 24 hrs