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Monoclonal Antibodies

CC-93269 for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

History of multiple myeloma with relapsed and refractory disease

Eastern Cooperative Oncology Group Performance Status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 63 months

Awards & highlights

Study Summary

This trial is testing a new drug for people with multiple myeloma that has come back or does not respond to treatment.

Who is the study for?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. Participants should be fairly active and able to care for themselves (ECOG Performance Status of 0 or 1) and have measurable signs of the disease. They can't join if they've had certain stem cell transplants recently, are dealing with another cancer needing treatment, or if their myeloma affects the central nervous system.Check my eligibility

What is being tested?

The study tests CC-93269, a new therapy designed to engage T cells in attacking cancer cells. It's an early-phase trial where doses will be increased gradually (Parts A and C) before being given to more patients at those levels (Parts B and D). The goal is to find out how safe it is and what effects it has on this type of blood cancer.See study design

What are the potential side effects?

As CC-93269 is a first-in-human study, specific side effects aren't fully known yet. Generally, therapies like this may cause immune reactions, fatigue, fever, nausea or affect blood counts leading to higher infection risk.

Eligibility Criteria

Inclusion Criteria

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

Select...

My multiple myeloma has come back and is not responding to treatment.

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 63 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 63 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 63 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events (AEs)

Dose Limiting Toxicity (DLT)

Maximum Tolerated Dose (MTD)

+1 more

Secondary outcome measures

Duration of Response

Overall Response Rate (ORR)

Overall Survival

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of CC-93269Experimental Treatment1 Intervention

CC-93269 will be administered to each patient on a 28-day cycle

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,604 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,613 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,573 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,037 Patients Enrolled for Multiple Myeloma

Michael R Burgess, MD, PhDStudy DirectorCelgene

Media Library

CC-93269 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03486067 — Phase 1

Multiple Myeloma Research Study Groups: Administration of CC-93269

Multiple Myeloma Clinical Trial 2023: CC-93269 Highlights & Side Effects. Trial Name: NCT03486067 — Phase 1

CC-93269 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03486067 — Phase 1

Frequently Asked Questions

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

What are the primary goals of this trial to accomplish?

"According to the trial sponsor, Celgene, this medical research will assess its primary outcome of Dose Limiting Toxicity (DLT) over a span of up to 60 months. Additionally, secondary outcomes such as Overall Response Rate (ORR), Progression Free Survival and Pharmacokinetics - CL are also being monitored. Respectively these metrics measure International Myeloma Working Group (IMWG) response criteria achievement, time until progressive disease or death from any cause occurs after first drug dose administration and apparent total body clearance respectively."

Answered by AI

Are there various healthcare centers conducting this research experiment in the US?

"This clinical trial has 10 enrolment sites, with the University Of Alabama At Birmingham in Birmingham, Yale Cancer Center in New Haven and University of Alabama at Birmingham in Seattle being amongst them. Additionally, there are 7 other locations available for patient participation."

Answered by AI

Are investigators currently recruiting participants for this research experiment?

"According to clinicaltrials.gov, this particular medical experiment has ceased recruiting patients since November 8th 2022 and was initially posted on April 3rd 2018. However, there are still 807 other trials actively searching for participants."

Answered by AI

Has CC-93269 been given the endorsement of the FDA?

"The safety of CC-93269 is somewhat uncertain due to the rudimentary nature of this Phase 1 study, and it was consequently rated a 1 out of 3 by our Power team."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

2018. "Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03486067.

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