Relapsed/Refractory Multiple MyelomaNCT07689006
Real-World Clinical Outcomes in Relapsed/Refractory Multiple Myeloma Treated With Pomalidomide Regimens
An observational study of Relapsed/Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This retrospective observational study will use data from the OneOncology United States database to evaluate clinical outcomes in adults with relapsed/refractory multiple myeloma who received pomalidomide-containing or non-pomalidomide-containing treatment as second-line or third-line therapy after prior exposure to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Pomalidomide-containing regimens and Non-pomalidomide-containing regimens
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to 28 Mar 2025
- Phase
- Observational
- 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
Study population: Adults with relapsed/refractory multiple myeloma treated in the OneOncology United States database who previously received both a lenalidomide-containing regimen and a proteasome inhibitor and subsequently initiated specified pomalidomide-containing or non-pomalidomide-containing regimens in the second-line or third-line setting.
Who may be able to join
- Have a diagnosis of multiple myeloma (ICD-9: 203.00; ICD-10: C90.0x, C90)
- Are ≥18 years of age at the index date
- Have received a lenalidomide-containing regimen and received a proteasome inhibitor; exposures do not need to occur within the same line of therapy
- Have received ≥1 subsequent lines of therapy after lenalidomide and proteasome inhibitor exposure
- Have received one of the following treatment regimens as the subsequent line (index line) after lenalidomide and proteasome inhibitor exposure:
- Pomalidomide-containing regimens:
Show all 12Show fewer
- Daratumumab, pomalidomide, and dexamethasone (DPd)
- Carfilzomib, pomalidomide, and dexamethasone (KPd)
- Non-pomalidomide-containing regimens:
- Daratumumab, lenalidomide, and dexamethasone (DRd; lenalidomide-refractory participants only)
- Daratumumab, bortezomib, and dexamethasone (DVd)
- Daratumumab, carfilzomib, and dexamethasone (DKd)
Who cannot join
- Have <6 months of follow-up from the index date; participants who died will be included even with <6 months follow-up, but participants who died within 1 month after the index date will be excluded
- Have <6 months pre-index enrollment
- Have other primary cancer diagnoses within 1 year pre-index
- Excluded ICD-10 diagnosis codes: C00.xx-C76.xx, C7A, C80.xx-C88.xx, C91.xx-C96.xx, D00.xx-D09.xx, D37.xx-D47.1x, D47.3x-D49.xx
- Excluded ICD-9 diagnosis codes: 149.x through 239.x
- ICD codes 209.4, 209.5, 209.6, 209.7, D47.Z1, D47.Z2, and D3A will not be excluded
- Received chimeric antigen receptor T-cell therapy or bispecific antibody therapy before index date or as the index line
- Have ever enrolled in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Receiving Pomalidomide-Containing and Non-Pomalidomide-Containing Regimens in the Real World: A OneOncology United States Database Study
This retrospective observational study will use data from the OneOncology United States database to evaluate clinical outcomes in adults with relapsed/refractory multiple myeloma who received pomalidomide-containing or non-pomalidomide-containing treatment as second-line or third-line therapy after prior exposure to lenalidomide and a proteasome inhibitor.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Pomalidomide-containing regimens, Non-pomalidomide-containing regimens
- Keywords
- Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide-containing regimensDrug
Exposure to pomalidomide-containing index regimens, including daratumumab, pomalidomide, and dexamethasone (DPd) and carfilzomib, pomalidomide, and dexamethasone (KPd), administered in routine clinical practice.
Non-pomalidomide-containing regimensDrug
Exposure to non-pomalidomide-containing index regimens, including daratumumab, lenalidomide, and dexamethasone (DRd), daratumumab, bortezomib, and dexamethasone (DVd), and daratumumab, carfilzomib, and dexamethasone (DKd), administered in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide-containing regimens | Participants who initiated daratumumab, pomalidomide, and dexamethasone (DPd) or carfilzomib, pomalidomide, and dexamethasone (KPd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor. Receives: Drug: Pomalidomide-containing regimens | |
| Non-pomalidomide-containing regimens | Participants who initiated daratumumab, lenalidomide, and dexamethasone (DRd), or daratumumab, bortezomib, and dexamethasone (DVd), or daratumumab, carfilzomib, and dexamethasone (DKd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor. Receives: Drug: Non-pomalidomide-containing regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens
Measured: Up to 6 years
Overall Survival (OS) among participants who initiated pomalidomide-containing index regimens
Measured: Up to 6 years
Overall Response Rate (ORR) among participants who initiated pomalidomide-containing index regimens
Measured: Up to 6 years
Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens
TTNT is defined as the time from initiation of the pomalidomide-containing index regimen to initiation of the next subsequent line of therapy.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start23 Dec 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- 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
- NCT07689006
- Sponsor's protocol ID
- CA077-1012
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Receiving Pomalidomide-Containing and Non-Pomalidomide-Containing Regimens in the Real World: A OneOncology United States Database Study
- ClinicalTrials.gov ID
- NCT07689006
- Acronym / sponsor ID
- CA077-1012
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 7 Jul 2026 (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.
This retrospective observational study will use data from the OneOncology United States database to evaluate clinical outcomes in adults with relapsed/refractory multiple myeloma who received pomalidomide-containing or non-pomalidomide-containing treatment as second-line or third-line therapy after prior exposure to lenalidomide and a proteasome inhibitor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide-containing regimens | – | Drug: Pomalidomide-containing regimensParticipants who initiated daratumumab, pomalidomide, and dexamethasone (DPd) or carfilzomib, pomalidomide, and dexamethasone (KPd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor. |
| Non-pomalidomide-containing regimens | – | Drug: Non-pomalidomide-containing regimensParticipants who initiated daratumumab, lenalidomide, and dexamethasone (DRd), or daratumumab, bortezomib, and dexamethasone (DVd), or daratumumab, carfilzomib, and dexamethasone (DKd) index regimens in the 2L or 3L setting after prior exposure to lenalidomide and a proteasome inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with relapsed/refractory multiple myeloma treated in the OneOncology United States database who previously received both a lenalidomide-containing regimen and a proteasome inhibitor and subsequently initiated specified pomalidomide-containing or non-pomalidomide-containing regimens in the second-line or third-line setting.
Key inclusion criteria (12 listed)
- Have a diagnosis of multiple myeloma (ICD-9: 203.00; ICD-10: C90.0x, C90)
- Are ≥18 years of age at the index date
- Have received a lenalidomide-containing regimen and received a proteasome inhibitor; exposures do not need to occur within the same line of therapy
- Have received ≥1 subsequent lines of therapy after lenalidomide and proteasome inhibitor exposure
- Have received one of the following treatment regimens as the subsequent line (index line) after lenalidomide and proteasome inhibitor exposure:
Key exclusion criteria (8 listed)
- Have <6 months of follow-up from the index date; participants who died will be included even with <6 months follow-up, but participants who died within 1 month after the index date will be excluded
- Have <6 months pre-index enrollment
- Have other primary cancer diagnoses within 1 year pre-index
- Received chimeric antigen receptor T-cell therapy or bispecific antibody therapy before index date or as the index line
- Have ever enrolled in a clinical trial
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 |
|---|---|---|
| Pomalidomide-containing regimensExposure to pomalidomide-containing index regimens, including daratumumab, pomalidomide, and dexamethasone (DPd) and carfilzomib, pomalidomide, and dexamethasone (KPd), administered in routine clinical practice. | Drug | Pomalidomide-containing regimens |
| Non-pomalidomide-containing regimensExposure to non-pomalidomide-containing index regimens, including daratumumab, lenalidomide, and dexamethasone (DRd), daratumumab, bortezomib, and dexamethasone (DVd), and daratumumab, carfilzomib, and dexamethasone (DKd), administered in routine clinical practice. | Drug | Non-pomalidomide-containing regimens |
Primary outcome
Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens
Time frame: Up to 6 years
Overall Survival (OS) among participants who initiated pomalidomide-containing index regimens
Time frame: Up to 6 years
Overall Response Rate (ORR) among participants who initiated pomalidomide-containing index regimens
Time frame: Up to 6 years
Time to Next Treatment (TTNT) among participants who initiated pomalidomide-containing index regimens
Time frame: Up to 6 years
TTNT is defined as the time from initiation of the pomalidomide-containing index regimen to initiation of the next subsequent line of therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in United States.
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 12 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-Free Survival (PFS) among participants who initiated pomalidomide-containing index regimens (time frame: Up to 6 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 7 Jul 2026.