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

NCT ID: NCT04436029

Last Updated: 2024-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2022-04-09

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Descartes 11

Group Type EXPERIMENTAL

Descartes 11

Intervention Type BIOLOGICAL

Car T-cells

Interventions

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Descartes 11

Car T-cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cartesian Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Stephenson Cancer Center Oklahoma University Health Science Centers

Oklahoma City, Oklahoma, United States

Site Status

Medical College of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.

Reference Type DERIVED
PMID: 35285981 (View on PubMed)

Mohan M, Hari P, Szabo A, Dhakal B, Chhabra S, D'Souza A. Long term follow up of newly diagnosed multiple myeloma patients treated with pembrolizumab consolidation post-autologous stem cell transplantation. Leuk Res. 2021 Oct;109:106648. doi: 10.1016/j.leukres.2021.106648. Epub 2021 Jun 23. No abstract available.

Reference Type DERIVED
PMID: 34182226 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DC 11B

Identifier Type: -

Identifier Source: org_study_id