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Monoclonal Antibodies

Treatment (cyclophosphamide, dexamethasone, TiNK, isatuximab) for Multiple Myeloma

Phase 1

Recruiting

Led By Elvira Umyarova, MD

Research Sponsored by Elvira Umyarova

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calculated creatinine clearance of ≥ 30ml/min using Modification of Diet in Renal Disease (MDRD) formula

No New York Heart Association class III-IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to the date of his or her death, at 1 year

Awards & highlights

Study Summary

This trial is testing a new treatment for patients with multiple myeloma that has come back or has not responded to previous treatment. The treatment involves using special white blood cells called NK cells, which are

Who is the study for?

This trial is for patients with multiple myeloma that has either returned after treatment or hasn't responded to previous therapies. Participants must meet certain health standards, which are not specified here.Check my eligibility

What is being tested?

The study is testing the safety and optimal dosage of lab-enhanced NK cells (TiNK) combined with isatuximab, alongside standard treatments cyclophosphamide and dexamethasone, in treating relapsed or refractory multiple myeloma.See study design

What are the potential side effects?

Potential side effects include immune system reactions, damage to normal cells leading to various symptoms, increased risk of infections due to lowered immunity from cyclophosphamide, and inflammation reduction complications from dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough, with a creatinine clearance of 30ml/min or more.

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My heart functions well enough for most daily activities.

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I can perform daily activities with minimal assistance.

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I am 18 or older with a relapse or no response to treatment, as per IMWG criteria.

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I've had 3 treatments including lenalidomide, a proteasome inhibitor, anti-CD38 or anti-SLAMF7 antibody, and BCMA therapy.

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My heart rhythm is stable without uncontrolled irregularities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until disease progression or death, at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until disease progression or death, at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until disease progression or death, at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of adverse events (AE)

Secondary outcome measures

Change in quality of life (QOL) using EORTC QLQ-MY20

Change in quality of life (QOL) using PROMIS G10

Duration of response

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cyclophosphamide, dexamethasone, TiNK, isatuximab)Experimental Treatment8 Interventions

Patients receive cyclophosphamide IV on day 1, dexamethasone PO on days 1-4, TiNK IV on day 8, and isatuximab IV on days 8 and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening and on study, as well as optionally during follow up. Patients undergo ECHO during screening and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11670

Cyclophosphamide

1995

Completed Phase 3

~3770

Biospecimen Collection

2004

Completed Phase 2

~1700

Dexamethasone

2007

Completed Phase 4

~2590

Isatuximab

2016

Completed Phase 3

~370

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,950 Total Patients Enrolled

47 Trials studying Multiple Myeloma

10,171 Patients Enrolled for Multiple Myeloma

Elvira UmyarovaLead Sponsor

Elvira Umyarova, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"According to the information provided on clinicaltrials.gov, this specific trial is currently not seeking participants. The initial posting of this study was made on February 1st, 2024, and it was last updated on January 2nd, 2024. However, please note that there are still a noteworthy number of other trials—797 in total—that are actively accepting patients at this time."

Answered by AI

Has the combination treatment involving cyclophosphamide, dexamethasone, TiNK, and isatuximab received approval from the FDA?

"Given that this trial is in Phase 1, meaning there is limited data supporting both the safety and efficacy of Treatment (cyclophosphamide, dexamethasone, TiNK, isatuximab), our team at Power rates its safety as a 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma

Elvira Umyarova 2024. "Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203912.