Multiple MyelomaPhase 1NCT06163898
A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing Alnuctamab, Mezigdomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 6 sites in 2 countries.
Trial summary
The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma. 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?
- Alnuctamab, Mezigdomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 27 Feb 2024to 3 Jun 2025
- 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
- Participant has a history of RRMM, and must:
- Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy.
- Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy.
Who cannot join
- Must not have previously received alnuctamab or mezigdomide.
- Note: Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
Local Institution - 0033
Birmingham, Alabama, 35294
Local Institution - 0035
New Haven, Connecticut, 06511
Local Institution - 0018
New York, New York, 10065
Israel3 sites
Local Institution - 0020
Jerusalem, 9112001
Local Institution - 0021
Petah Tikva, Central District, 4910021
Local Institution - 0030
Ramat Gan, Central District, 5262100
About this study
Official title: A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Alnuctamab, Mezigdomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlnuctamabDrug
Also called BMS-986349, CC-93269, EM901
Specified dose on specified days
MezigdomideDrug
Also called BMS-986348, CC-92480
Specified dose on specified days
DexamethasoneDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Alnuctamab; Drug: Mezigdomide; Drug: Dexamethasone |
| Arm B1 | Experimental | Not described Receives: Drug: Alnuctamab; Drug: Mezigdomide; Drug: Dexamethasone |
| Arm B2 | Experimental | Not described Receives: Drug: Alnuctamab; Drug: Mezigdomide; Drug: Dexamethasone |
| Arm C1 | Experimental | Not described Receives: Drug: Alnuctamab; Drug: Mezigdomide; Drug: Dexamethasone |
| Arm C2 | Experimental | Not described Receives: Drug: Alnuctamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with serious AEs (SAEs)
Measured: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with AEs leading to discontinuation
Measured: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of deaths
Measured: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with Dose-limiting toxicities (DLTs)
Measured: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Overall Response Rate (ORR)
Phase 2 only
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Secondary outcomes (7)
Complete Response Rate (CRR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Very Good Partial Response Rate (VGPRR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Progression-free Survival (PFS)
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Time-to-Response (TTR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Duration of Response (DOR)
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Overall Survival (OS)
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
ORR
Phase 1 only
Measured: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start27 Feb 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163898
- Sponsor's protocol ID
- CA058-002
- Other IDs
- 2023-504367-16-00, U1111-1283-8970, 2023
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06163898
- Acronym / sponsor ID
- CA058-002
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 11 Dec 2023 (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.
The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Alnuctamab, Drug: Mezigdomide, Drug: Dexamethasone |
| Arm B1 | Experimental | Drug: Alnuctamab, Drug: Mezigdomide, Drug: Dexamethasone |
| Arm B2 | Experimental | Drug: Alnuctamab, Drug: Mezigdomide, Drug: Dexamethasone |
| Arm C1 | Experimental | Drug: Alnuctamab, Drug: Mezigdomide, Drug: Dexamethasone |
| Arm C2 | Experimental | Drug: Alnuctamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy.
- Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy.
Key exclusion criteria (2 listed)
- Must not have previously received alnuctamab or mezigdomide.
- Note: Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| AlnuctamabAlso: BMS-986349, CC-93269, EM901Specified dose on specified days | Drug | Arm B1, Arm B2, Arm C1, Arm C2, Part A |
| MezigdomideAlso: BMS-986348, CC-92480Specified dose on specified days | Drug | Arm B1, Arm B2, Arm C1, Part A |
| DexamethasoneSpecified dose on specified days | Drug | Arm B1, Arm B2, Arm C1, Part A |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with serious AEs (SAEs)
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with AEs leading to discontinuation
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of deaths
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with Dose-limiting toxicities (DLTs)
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Overall Response Rate (ORR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Phase 2 only
7 secondary outcomes
Complete Response Rate (CRR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Very Good Partial Response Rate (VGPRR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Progression-free Survival (PFS)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Time-to-Response (TTR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Duration of Response (DOR)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
Overall Survival (OS)
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
ORR
Time frame: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)
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 21 Apr 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alnuctamab, Mezigdomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 6 sites in 2 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 3 inclusion and 2 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Israel. 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?
Number of participants with adverse events (AEs) (time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.