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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: Descartes 11

• Registration Number: NCT04436029
• Lead Sponsor: Cartesian Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Study Start: 2021-02-24
• Primary Completion: 2022-02-18
• Study Completion: 2022-04-09
• Results First Submitted: 2023-05-25
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Results First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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).

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Exclusion Criteria

• Patients who are pregnant or lactating.
• Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Descartes 11	Descartes 11	-

Primary Outcome Measures

Name	Time	Method
Rate of Stringent Complete Response	1 year	Per IMWG 2016 Response Criteria Summary sCR: Complete response (CR) plus a normal free light chain ratio and no clonal cells in bone marrow (by immunohistochemistry). The FLC ratio must be Kappa/Lambda ≤ 4:1 or ≥ 1:2 after counting at least 100 plasma cells. CR: Negative immunofixation in serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. VGPR: Serum M-protein detectable by immunofixation (not on electrophoresis) or a ≥ 90% reduction in M-protein, with urine M-protein \<100 mg/24 hours. PR: ≥ 50% reduction in serum M-protein and a ≥ 90% reduction in 24-hour urinary M-protein (or to \<200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required. If both M-protein and serum-free light chains are unmeasurable, a ≥ 50% reduction in plasma cells is necessary, provided baseline plasma-cell percentage in bone marrow was ≥ 30%. Overall Response (OR): CR+VGPR+PR

Trial Locations

Locations (4)

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Stephenson Cancer Center Oklahoma University Health Science Centers; 🇺🇸 Oklahoma City, Oklahoma, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Medical College of Wisconsin; 🇺🇸 Madison, Wisconsin, United States