Multiple MyelomaNCT06160167
Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to measure the incidence of hyperpigmentation in Black participants with multiple myeloma (MM) treated with immunomodulatory drugs (IMiDs) compared with Black participants with MM not treated with IMiDs. 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?
- IMiD treatment, No IMiD treatment and Systemic therapy
- How many people
- 4,204 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Aug 2024
- 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: Black and non-Black participants with MM
Who may be able to join
- Participants ≥18 years of age at index date
- Participants with new diagnosis of MM as defined by:
- ICD-9-CM: 203.0x and/or ICD-10-CM: C90.0x or C90 during the study period
- At least two documented clinical visits for MM on different days and occurring on or after January 1, 2011
- Participants who received at least one systemic MM therapy on or after initial MM diagnosis
- Participants who did not receive clinical study drug at any time during the observation period
- Participants with race information
Who cannot join
- Patients with less than 6 months of medical data during the prior or follow-up period
- Patients in more than one race category (mix race), missing race, unknown race, and "other" race
- Patients diagnosed with the following hematological cancers on or prior to the index date:
- myelodysplastic syndromes (ICD-9: 238.74, 238.75; ICD-10: D46.xx)
- mantle cell lymphoma (ICD-9: 200.4x, ICD-10: C83.1x)
- follicular lymphoma (ICD-9: 202.0x, ICD-10: C82.xx)
Show all 14Show fewer
- marginal zone lymphoma (ICD-9: 200.3x, ICD-10: C83.4x)
- Patients with evidence of skin hyperpigmentation (ICD-9: 709.00, 709.09; ICD-10: L81.0, L81.1, L81.4, L81.8) on or prior to the index date
- 709.00 Dyschromia, unspecified
- 709.09 Other dyschromia
- L81.0 Post inflammatory hyperpigmentation
- L81.1 Chloasma/melasma
- L81.4 Other melanin hyperpigmentation
- L81.8 Other specified disorders of pigmentation
Trial locations and contacts
1 site in 1 country.
United States1 site
Flatiron Health Oncology Database
New York, New York, 10013
About this study
The purpose of this study is to measure the incidence of hyperpigmentation in Black participants with multiple myeloma (MM) treated with immunomodulatory drugs (IMiDs) compared with Black participants with MM not treated with IMiDs. The study will use de-identified data from electronic medical records in the Flatiron Health database.
- Conditions
- Multiple Myeloma
- Being tested
- IMiD treatment, No IMiD treatment, Systemic therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMiD treatmentDrug
Participants with MM treated with IMiDs
No IMiD treatmentDrug
Participants with MM not treated with IMiDs
Systemic therapyDrug
Participants with MM treated with systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Participants with MM treated with IMiDs | Not described Receives: Drug: IMiD treatment | |
| Participants with MM not treated with IMiDs | Not described Receives: Drug: No IMiD treatment | |
| Participants with MM treated with systemic therapy | Not described Receives: Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM
Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).
Measured: 12 months
Secondary outcomes (3)
Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM
Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).
Measured: 12 months
Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs
Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).
Measured: 12 months
Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM
Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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 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
- 4,204 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
- NCT06160167
- Sponsor's protocol ID
- CA078-1007
- Status last verified
- Aug 2024
- First submitted
- 29 Nov 2023
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
- ClinicalTrials.gov ID
- NCT06160167
- Acronym / sponsor ID
- CA078-1007
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,204 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 7 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 measure the incidence of hyperpigmentation in Black participants with multiple myeloma (MM) treated with immunomodulatory drugs (IMiDs) compared with Black participants with MM not treated with IMiDs. The study will use de-identified data from electronic medical records in the Flatiron Health database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with MM treated with IMiDs | – | Drug: IMiD treatment |
| Participants with MM not treated with IMiDs | – | Drug: No IMiD treatment |
| Participants with MM treated with systemic therapy | – | Drug: Systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Black and non-Black participants with MM
Key inclusion criteria (7 listed)
- Participants ≥18 years of age at index date
- Participants with new diagnosis of MM as defined by:
- Participants who received at least one systemic MM therapy on or after initial MM diagnosis
- Participants who did not receive clinical study drug at any time during the observation period
- Participants with race information
Key exclusion criteria (14 listed)
- Patients with less than 6 months of medical data during the prior or follow-up period
- Patients in more than one race category (mix race), missing race, unknown race, and "other" race
- Patients diagnosed with the following hematological cancers on or prior to the index date:
- Patients with evidence of skin hyperpigmentation (ICD-9: 709.00, 709.09; ICD-10: L81.0, L81.1, L81.4, L81.8) on or prior to the index date
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 |
|---|---|---|
| IMiD treatmentParticipants with MM treated with IMiDs | Drug | Participants with MM treated with IMiDs |
| No IMiD treatmentParticipants with MM not treated with IMiDs | Drug | Participants with MM not treated with IMiDs |
| Systemic therapyParticipants with MM treated with systemic therapy | Drug | Participants with MM treated with systemic therapy |
Primary outcome
Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM
Time frame: 12 months
Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).
3 secondary outcomes
Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM
Time frame: 12 months
Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs
Time frame: 12 months
Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM
Time frame: 12 months
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 23 Aug 2024.
- 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 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 7 inclusion and 14 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 23 Aug 2024. 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?
Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM (time frame: 12 months). 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 23 Aug 2024.