CC-99712 for Multiple Myeloma

No longer recruiting at 53 trial locations
Rs
Fl
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Celgene
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CC-99712 for people with multiple myeloma, a type of blood cancer, who have tried other treatments without success. The study will assess the safety and effectiveness of CC-99712 when administered alone or with another drug, BMS-986405. Individuals with multiple myeloma that recurs or resists treatment might be suitable for this trial. Participants will receive the treatment through an IV (intravenous infusion) and will continue until the disease progresses or they choose to stop. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CC-99712 is still undergoing safety testing in humans. This Phase 1 trial marks the first time this treatment is being tested in people. During this phase, researchers aim to determine the correct dose and monitor for any side effects.

Currently, there is limited information on how well people tolerate CC-99712 alone. Since this is its first human trial, the primary goal is to establish a safe dose and observe participant responses.

Safety data on the combination of CC-99712 with BMS-986405 is also limited. The trial examines how these drugs interact and what side effects may arise.

In Phase 1 trials like this, safety remains uncertain. Researchers seek to learn more about potential side effects and how to manage them. Participating in a trial at this stage contributes to gathering crucial safety information.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about CC-99712 for multiple myeloma because it introduces a new approach to treatment. Unlike traditional therapies such as proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, CC-99712 is administered via intravenous infusion and may offer a unique mechanism of action. In one treatment arm, CC-99712 is combined with BMS-986405, an oral medication, potentially enhancing its effectiveness. This combination could provide a dual approach to tackle the disease more effectively than current options. The innovation in both delivery and combination could lead to more effective treatment outcomes for patients with multiple myeloma.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research shows that CC-99712, one of the treatments in this trial, has promising results for people with multiple myeloma when used alone. In earlier studies, 60% of patients responded positively, with some even achieving complete remission, meaning no signs of cancer were found.

This trial will also study the combination of CC-99712 with another drug, BMS-986405. Studies for this combination are ongoing. CC-99712 specifically targets and attacks cancer cells, potentially making it a strong option for treating this condition. The focus is on how well these treatments can target multiple myeloma cells and improve patient outcomes.23467

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma that has come back or hasn't responded to treatment. They must have measurable disease and be in good physical condition (ECOG PS of 0 or 1). It's not for pregnant women, those with HIV, brain involvement of MM, recent stem cell transplants, or active hepatitis B/C.

Inclusion Criteria

My multiple myeloma has come back or is not responding to treatment.
You must have a specific, measurable health issue.
I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I am HIV positive.
Subject is a pregnant or lactating female.
I had a stem cell transplant less than 6 months ago or am on medication for graft-versus-host disease.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of CC-99712 to determine the maximum tolerated dose (MTD)

Up to 28 days
Multiple visits for dose administration and monitoring

Dose Expansion

Participants receive CC-99712 at or below the MTD to evaluate safety and efficacy

Up to 3 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

At least 42 days after completion of study treatment

What Are the Treatments Tested in This Trial?

Interventions

  • CC-99712
Trial Overview The study tests CC-99712 alone or with BMS-986405 on participants with relapsed/refractory multiple myeloma. Part A finds the highest dose they can give without bad side effects (MTD) and Part B checks how well it works at this dose.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm 2 (CC-99712 and BMS-986405 combination)Experimental Treatment2 Interventions
Group II: Arm 1 (CC-99712 monotherapy)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
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Jay Backstrom profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles profile image

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

Clinical Trial: NCT04036461A study of CC-99712, a BCMA antibody-drug conjugate, in participants with relapsed and refractory multiple myeloma.
A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in ...A study of CC-99712, a BCMA antibody-drug conjugate, in participants with relapsed and refractory multiple myeloma.
Targeting B Cell Maturation Antigen in Patients with ...In this review, we discuss the existing BCMA-targeted therapies and provide insights into currently available treatment and future developments, ...
A Study of CC-99712, a BCMA Antibody-Drug Conjugate ...A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma. Trial Status: administratively complete.
Multiple Myeloma Support + TrialsA Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma. Verified. Am I Eligible? Resources. Overview.
A Study of CC-99712, a BCMA Antibody-Drug Conjugate ...The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in ...
Antibody–Drug Conjugates for Multiple MyelomaExperimental arm 2: CC-99712 will be administered IV while BMS-986405 will be administered orally. ... safety data of Part 1. NCT04398745.
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