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Monoclonal Antibodies

CC-93269 for Multiple Myeloma

Phase 1
Waitlist Available
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
Must not have
Symptomatic central nervous system involvement of multiple myeloma
Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 63 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My multiple myeloma has spread to my brain and is causing symptoms.
Select...
I had a stem cell transplant less than a year ago.
Select...
I am currently receiving treatment for another type of cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events (AEs)
Dose Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD)
+1 more
Secondary study objectives
Duration of Response
Overall Response Rate (ORR)
Overall Survival
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
645 Previous Clinical Trials
130,182 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,556 Patients Enrolled for Multiple Myeloma
Michael R Burgess, MD, PhDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,569 Previous Clinical Trials
3,384,114 Total Patients Enrolled
76 Trials studying Multiple Myeloma
28,854 Patients Enrolled for Multiple Myeloma

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
~103 spots leftby Jun 2029
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