Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

NCT04816526 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: DC-08-B
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (1)

• Rate of Stringent Complete Response

  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

  8 months

Study Arms (1)

Descartes 08

EXPERIMENTAL

Biological: Descartes 08

Interventions

Descartes 08 BIOLOGICAL

Car T-cells

Descartes 08

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Cartesian Therapeutics: lead

Study Sites (2)

University of California Irvine

Orange, California, 92868, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Milos Miljkovic, Chief Medical Officer
• Organization: Cartesian Therapeutics

milos@cartesiantx.com

4436335855

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: December 1, 2021
• Primary Completion: August 4, 2022
• Study Completion: November 3, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Locations

US (2)