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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 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

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,705 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
3,369,731 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
~116 spots leftby Jun 2029