Multiple MyelomaPhase 1/2NCT03989414
A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
A Phase 1/2 study testing CC-92480, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Celgene at 49 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments. 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-92480, Bortezomib and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 49 sitesin 9 countries
- Study dates
- 30 Sep 2019to 30 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Who cannot join
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
United States16 sites
Local Institution - 108
Atlanta, Georgia, 30322
Local Institution - 117
Boston, Massachusetts, 02114
Local Institution - 101
Boston, Massachusetts, 02115
Local Institution - 118
Boston, Massachusetts, 02215
Local Institution - 112
Chicago, Illinois, 60611
Local Institution - 107
Chicago, Illinois, 60637
Local Institution - 115
Columbus, Ohio, 43210
Local Institution - 119
Denver, Colorado, 80218
Local Institution - 113
Detroit, Michigan, 48201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Local Institution - 116
Houston, Texas, 77030
Local Institution - 114
Nashville, Tennessee, 37203
Local Institution - 106
Rochester, Minnesota, 55905
Swedish Cancer Institute
Seattle, Washington, 98104
Local Institution - 104
Tampa, Florida, 33612
Local Institution - 110
Winston-Salem, North Carolina, 27157
Spain8 sites
Local Institution - 504
Badalona, 08916
Local Institution - 508
Madrid, 28022
Local Institution - 501
Madrid, 28041
Local Institution - 506
Málaga, 29010
Local Institution - 505
Pamplona, 31008
Local Institution - 502
Salamanca, 37007
Local Institution - 503
Santander, 39008
Local Institution - 507
Valencia, 46026
Canada5 sites
Local Institution - 201
Calgary, Alberta, T2N 4N2
Local Institution - 205
Edmonton, Alberta, T6G 2G3
Local Institution - 204
Halifax, Nova Scotia, B3H 1V7
Local Institution - 202
Montreal, Quebec, H1T 2M4
Local Institution - 203
Toronto, Ontario, M5G 2M9
France5 sites
Local Institution - 703
Lille, 59037
Local Institution - 705
Marseille, 13273
Local Institution - 704
Nantes, 44093
Local Institution - 701
Toulouse, 31059
Local Institution - 702
Tours, 37044
Germany5 sites
Local Institution - 604
Freiburg im Breisgau, 79106
Local Institution - 605
Hamburg, 20246
Local Institution - 601
Heidelberg, 69120
Local Institution - 602
München, 81675
Local Institution - 603
Würzburg, 97080
Italy4 sites
Local Institution - 404
Brescia, 25123
Local Institution - 401
Milan, 20133
Local Institution - 403
Reggio Emilia, 42100
Local Institution - 402
Torino, 10126
Czechia3 sites
Local Institution - 802
Brno, 625 00
Local Institution - 801
Ostrava-Poruba, 708 52
Local Institution - 803
Prague, 128 08
Denmark2 sites
Local Institution - 902
Odense, 5000
Local Institution - 903
Vejle, 7100
About this study
Official title: A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
- Conditions
- Multiple Myeloma
- Being tested
- CC-92480, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib
- Keywords
- Relapsed or Refractory Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Multiple Myeloma, CC-92480
- 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-92480Drug
Also called BMS-986348, mezigdomide
Specified dose on specified days
BortezomibDrug
Specified dose on specified days
DexamethasoneDrug
Specified dose on specified days
DaratumumabDrug
Specified dose on specified days
CarfilzomibDrug
Specified dose on specified days
ElotuzumabDrug
Specified dose on specified days
IsatuximabDrug
Specified dose on specified days
CarfilzomibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: CC-92480 with bortezomib and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Bortezomib; Drug: Dexamethasone |
| Cohort C: CC-92480 with carfilzomib and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Carfilzomib |
| Cohort H: CC-92480 with elotuzumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Elotuzumab |
| Cohort I: CC-92480 with isatuximab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Isatuximab |
| Cohort D: CC-92480 with bortezomib and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Bortezomib; Drug: Dexamethasone |
| Cohort F: CC-92480 with carfilzomib and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Carfilzomib |
| Cohort J: CC-92480 with elotuzumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Elotuzumab |
| Cohort K: CC-92480 with isatuximab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Isatuximab |
| Cohort G: CC-92480 with bortezomib and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Bortezomib; Drug: Dexamethasone |
| Subcohort B1: CC-92480 with daratumumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab |
| Subcohort B2: CC-92480 with daratumumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab |
| Subcohort B3: CC-92480 with daratumumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab |
| Subcohort E1: CC-92480 with daratumumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab |
| Subcohort E2: CC-92480 with daratumumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab |
| Subcohort E3: CC-92480 with daratumumab and dexamethasone | Experimental | Not described Receives: Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Dose
Measured: Up to approximately 3 years
Recommended regimen as measured by dose-limiting toxicities
Measured: Up to approximately 3 years
Number of participants with Adverse Events (AEs)
Measured: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
Overall response rate (ORR)
Measured: Up to approximately 5 years
Secondary outcomes (4)
Time-to-response (TTR)
Measured: Up to approximately 5 years
Duration of response (DOR)
Measured: Up to approximately 5 years
Complete Response (CR) rate
Measured: Up to approximately 5 years
Very good partial response (VGPR) rate - Cohorts D and E
Measured: 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 posted18 Jun 2019
- Study start30 Sep 2019
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
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
- NCT03989414
- Sponsor's protocol ID
- CC-92480-MM-002
- Other IDs
- U1111-1233-5619, 2023-505219-19, 2023
- Status last verified
- Oct 2024
- First submitted
- 14 Jun 2019
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
- ClinicalTrials.gov ID
- NCT03989414
- Acronym / sponsor ID
- CC-92480-MM-002
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed or Refractory Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Multiple Myeloma, CC-92480
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Jun 2019 (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 evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Cohort A: CC-92480 with bortezomib and dexamethasone | Experimental | Drug: CC-92480, Drug: Bortezomib, Drug: Dexamethasone |
| Cohort C: CC-92480 with carfilzomib and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Carfilzomib |
| Cohort H: CC-92480 with elotuzumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Elotuzumab |
| Cohort I: CC-92480 with isatuximab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Isatuximab |
| Cohort D: CC-92480 with bortezomib and dexamethasone | Experimental | Drug: CC-92480, Drug: Bortezomib, Drug: Dexamethasone |
| Cohort F: CC-92480 with carfilzomib and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Carfilzomib |
| Cohort J: CC-92480 with elotuzumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Elotuzumab |
| Cohort K: CC-92480 with isatuximab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Isatuximab |
| Cohort G: CC-92480 with bortezomib and dexamethasone | Experimental | Drug: CC-92480, Drug: Bortezomib, Drug: Dexamethasone |
| Subcohort B1: CC-92480 with daratumumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Daratumumab |
| Subcohort B2: CC-92480 with daratumumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Daratumumab |
| Subcohort B3: CC-92480 with daratumumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Daratumumab |
| Subcohort E1: CC-92480 with daratumumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Daratumumab |
| Subcohort E2: CC-92480 with daratumumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Daratumumab |
| Subcohort E3: CC-92480 with daratumumab and dexamethasone | Experimental | Drug: CC-92480, Drug: Dexamethasone, Drug: Daratumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Key exclusion criteria (5 listed)
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
- 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 |
|---|---|---|
| CC-92480Also: BMS-986348, mezigdomideSpecified dose on specified days | Drug | Cohort A: CC-92480 with bortezomib and dexamethasone, Cohort C: CC-92480 with carfilzomib and dexamethasone, Cohort D: CC-92480 with bortezomib and dexamethasone, Cohort F: CC-92480 with carfilzomib and dexamethasone, Cohort G: CC-92480 with bortezomib and dexamethasone, Cohort H: CC-92480 with elotuzumab and dexamethasone, Cohort I: CC-92480 with isatuximab and dexamethasone, Cohort J: CC-92480 with elotuzumab and dexamethasone, Cohort K: CC-92480 with isatuximab and dexamethasone, Subcohort B1: CC-92480 with daratumumab and dexamethasone, Subcohort B2: CC-92480 with daratumumab and dexamethasone, Subcohort B3: CC-92480 with daratumumab and dexamethasone, Subcohort E1: CC-92480 with daratumumab and dexamethasone, Subcohort E2: CC-92480 with daratumumab and dexamethasone, Subcohort E3: CC-92480 with daratumumab and dexamethasone |
| BortezomibSpecified dose on specified days | Drug | Cohort A: CC-92480 with bortezomib and dexamethasone, Cohort D: CC-92480 with bortezomib and dexamethasone, Cohort G: CC-92480 with bortezomib and dexamethasone |
| DexamethasoneSpecified dose on specified days | Drug | Cohort A: CC-92480 with bortezomib and dexamethasone, Cohort C: CC-92480 with carfilzomib and dexamethasone, Cohort D: CC-92480 with bortezomib and dexamethasone, Cohort F: CC-92480 with carfilzomib and dexamethasone, Cohort G: CC-92480 with bortezomib and dexamethasone, Cohort H: CC-92480 with elotuzumab and dexamethasone, Cohort I: CC-92480 with isatuximab and dexamethasone, Cohort J: CC-92480 with elotuzumab and dexamethasone, Cohort K: CC-92480 with isatuximab and dexamethasone, Subcohort B1: CC-92480 with daratumumab and dexamethasone, Subcohort B2: CC-92480 with daratumumab and dexamethasone, Subcohort B3: CC-92480 with daratumumab and dexamethasone, Subcohort E1: CC-92480 with daratumumab and dexamethasone, Subcohort E2: CC-92480 with daratumumab and dexamethasone, Subcohort E3: CC-92480 with daratumumab and dexamethasone |
| DaratumumabSpecified dose on specified days | Drug | Subcohort B1: CC-92480 with daratumumab and dexamethasone, Subcohort B2: CC-92480 with daratumumab and dexamethasone, Subcohort B3: CC-92480 with daratumumab and dexamethasone, Subcohort E1: CC-92480 with daratumumab and dexamethasone, Subcohort E2: CC-92480 with daratumumab and dexamethasone, Subcohort E3: CC-92480 with daratumumab and dexamethasone |
| CarfilzomibSpecified dose on specified days | Drug | Cohort C: CC-92480 with carfilzomib and dexamethasone |
| ElotuzumabSpecified dose on specified days | Drug | Cohort H: CC-92480 with elotuzumab and dexamethasone, Cohort J: CC-92480 with elotuzumab and dexamethasone |
| IsatuximabSpecified dose on specified days | Drug | Cohort I: CC-92480 with isatuximab and dexamethasone, Cohort K: CC-92480 with isatuximab and dexamethasone |
| CarfilzomibSpecified dose on specified days | Drug | Cohort F: CC-92480 with carfilzomib and dexamethasone |
Primary outcome
Recommended Dose
Time frame: Up to approximately 3 years
Recommended regimen as measured by dose-limiting toxicities
Time frame: Up to approximately 3 years
Number of participants with Adverse Events (AEs)
Time frame: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
Overall response rate (ORR)
Time frame: Up to approximately 5 years
4 secondary outcomes
Time-to-response (TTR)
Time frame: Up to approximately 5 years
Duration of response (DOR)
Time frame: Up to approximately 5 years
Complete Response (CR) rate
Time frame: Up to approximately 5 years
Very good partial response (VGPR) rate - Cohorts D and E
Time frame: Up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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/
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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
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CC-92480, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Celgene at 49 sites in 9 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Spain, Canada, France, Germany and 4 more countries. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Recommended Dose (time frame: Up to approximately 3 years). The study lists 4 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 29 Nov 2024.