Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma

A Phase 1 study testing CC-92328 in people with Multiple Myeloma, run by Celgene at 15 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: CC-92328
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 15 sitesin 3 countries
Study dates: 5 Oct 2021to 18 Jun 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must satisfy the following criteria to be enrolled in the study:
must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
willing and able to adhere to the study visit schedule and other protocol requirements.
Participant is ≥ 18 years of age the time of signing the ICF.
Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.
Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.

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Participant must have measurable disease.
Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Females of childbearing potential (FCBP) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 12 weeks after the last dose of CC-92328
Males must practice true abstinence or agree to use a condom
FCBP and males must avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of CC-92328.

Who cannot join

The presence of any of the following will exclude a participant from enrollment:
Participant has symptomatic central nervous system involvement of MM.
Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
Participant is a pregnant or lactating female.

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Participant received live virus vaccines within at least 4 weeks prior to starting study drug.
Participant has known active human immunodeficiency virus (HIV) infection.
Participant has active hepatitis B or C (HBV/HCV) infection.
Participant weight is ≤ 40 kg at screening.

Trial locations and contacts

15 sites in 3 countries.

Country

City, postcode or hospital

15 sites in 3 countries

United States6 sites

Local Institution - 104
Birmingham, Alabama, 35233
Local Institution - 101
Milwaukee, Wisconsin, 53226
Local Institution - 108
New York, New York, 10021
Local Institution - 107
New York, New York, 10029
Local Institution - 105
Scottsdale, Arizona, 85258
Local Institution - 106
Tampa, Florida, 33612

Other trials in United States

Canada5 sites

Local Institution - 201
Calgary, Alberta, T2N 4N2
Local Institution - 204
Edmonton, Alberta, T6G 1Z2
Local Institution - 203
Halifax, Nova Scotia, B3H 2Y9
Local Institution - 205
Montreal, Quebec, H4A3J1
Local Institution - 202
Toronto, Ontario, M5G 2M9

Other trials in Canada

Spain4 sites

Local Institution - 301
Badalona, 8916
Local Institution - 302
Pamplona, Navarre, 31008
Local Institution - 303
Salamanca, 37007
Local Institution - 304
Santander, 39008

Other trials in Spain

About this study

Official title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Conditions: Multiple Myeloma
Being tested: CC-92328
Keywords: Multiple Myeloma, First-in-human, Phase 1, Relapsed or Refractory, CC-92328
Medical subject headings: Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CC-92328Drug
CC-92328

Study groups in NCT04975399
Study group	Role	What they receive
Administration of CC-92328	Experimental	CC-92328 administered intravenously in 28-day cycles Receives: Drug: CC-92328

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-Limiting Toxicities (DLTs)
Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to the underlying disease or extraneous causes.
Measured: Up to 28 days after the first dose
Maximum Tolerated Dose (MTD)
Defined as the highest dose at which less than 33% of the population treated with CC-92328 experience a dose-limiting toxicity (DLT) in the first cycle and at least 6 evaluable participants have been treated at this dose level.
Measured: Up to 12 weeks after the last dose
Incidence of Adverse Events (AEs)
Type, frequency, seriousness, severity and relationship of AEs to CC-92328.
Measured: Up to 12 weeks after the last dose

Secondary outcomes (15)

Preliminary Efficacy - Overall Response Rate (ORR)
Defined as the proportion of participants who achieve a partial response (PR) or better according to IMWG response criteria.
Measured: Up to approximately 2 years
Preliminary Efficacy - Time to response
Defined as the time from the first CC-92328 dose date to the date of first documented response (PR or better).
Measured: Up to approximately 2 years
Preliminary Efficacy - Duration of response
Defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Measured: Up to approximately 2 years
Preliminary Efficacy - Progression-free Survival (PFS)
Defined as the time from the first dose of CC-92328 to pharmacodynamics (PD) or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Preliminary Efficacy - Overall Survival (OS)
Defined as the time from the first dose of CC-92328 to death from any cause.
Measured: Up to approximately 2 years
Pharmacokinetics - Cmax
Maximum serum concentration of drug.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Cmin
Minimum serum concentration of drug.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - AUC
Area under the curve.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - t1/2
Half-life.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - CL
Total body clearance of the drug from the serum.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Vd
Volume of distribution.
Measured: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Accumulation index of CC-92328
Calculated from the serum concentration-time data of CC-92328 using non-compartment methods.
Measured: Day 1 to 9 weeks after last dose of study drug
Presence of Anti-CC92328 antibodies (ADA)
Determined using a validated bridging immunoassay with electrochemiluminescence detection.
Measured: Day 1 to 9 weeks after last dose of study drug
Frequency of Anti-CC92328 antibodies (ADA)
Determined using a validated bridging immunoassay with electrochemiluminescence detection.
Measured: Day 1 to 9 weeks after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202118 Jun 2024

First posted23 Jul 2021
Study start5 Oct 2021
Primary completion18 Jun 2024
Study completion18 Jun 2024

Why it stopped: Business objectives have changed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by CelgeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04975399
Sponsor's protocol ID: CC-92328-MM-001
Other IDs: 2020-005968-64
Status last verified: Mar 2025
First submitted: 14 Jul 2021
Last updated: 24 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT04975399
Acronym / sponsor ID: CC-92328-MM-001
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, First-in-human, Phase 1, Relapsed or Refractory, CC-92328
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business objectives have changed
Enrolment: 26 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 5 Oct 2021 (actual)
Primary completion: 18 Jun 2024 (actual)
Study completion: 18 Jun 2024 (actual)
First posted: 23 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Administration of CC-92328	Experimental	Drug: CC-92328CC-92328 administered intravenously in 28-day cycles

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
willing and able to adhere to the study visit schedule and other protocol requirements.
Participant is ≥ 18 years of age the time of signing the ICF.
Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.
Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.

Key exclusion criteria (10 listed)

Participant has symptomatic central nervous system involvement of MM.
Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
Participant is a pregnant or lactating female.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CC-92328CC-92328	Drug	Administration of CC-92328

Primary outcome

Dose-Limiting Toxicities (DLTs)
Time frame: Up to 28 days after the first dose
Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to the underlying disease or extraneous causes.
Maximum Tolerated Dose (MTD)
Time frame: Up to 12 weeks after the last dose
Defined as the highest dose at which less than 33% of the population treated with CC-92328 experience a dose-limiting toxicity (DLT) in the first cycle and at least 6 evaluable participants have been treated at this dose level.
Incidence of Adverse Events (AEs)
Time frame: Up to 12 weeks after the last dose
Type, frequency, seriousness, severity and relationship of AEs to CC-92328.

15 secondary outcomes

Preliminary Efficacy - Overall Response Rate (ORR)
Time frame: Up to approximately 2 years
Preliminary Efficacy - Time to response
Time frame: Up to approximately 2 years
Preliminary Efficacy - Duration of response
Time frame: Up to approximately 2 years
Preliminary Efficacy - Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Preliminary Efficacy - Overall Survival (OS)
Time frame: Up to approximately 2 years
Pharmacokinetics - Cmax
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Cmin
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - AUC
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - tmax
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - t1/2
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - CL
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Vd
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Accumulation index of CC-92328
Time frame: Day 1 to 9 weeks after last dose of study drug
Presence of Anti-CC92328 antibodies (ADA)
Time frame: Day 1 to 9 weeks after last dose of study drug
Frequency of Anti-CC92328 antibodies (ADA)
Time frame: Day 1 to 9 weeks after last dose of study drug

Results and safety

The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

15 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-92328 in people with Multiple Myeloma, run by Celgene at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities (DLTs) (time frame: Up to 28 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04975399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.