Relapsed or Refractory Multiple Myeloma
Conditions
Brief summary
This observational study aimed to assess the safety of elotuzumab when used in combination with pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma (RRMM) in participants who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The study will also assess the safety of elotuzumab when used in combination with lenalidomide and dexamethasone in RRMM participants who had received one to three prior therapies.
Interventions
DRUGElotuzumab in combination with pomalidomide and dexamethasone
Participants who received elotuzumab in combination with pomalidomide and dexamethasone for RRMM and had ≥2 prior lines of therapy (including lenalidomide and a proteasome inhibitor)
Participants who received elotuzumab in combination with pomalidomide and dexamethasone for RRMM and had ≥2 prior lines of therapy (including lenalidomide and a proteasome inhibitor)
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Confirmed diagnosis of RRMM * Received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor * Planning to receive elotuzumab in combination with pomalidomide and dexamethasone at physician's medical judgement OR * Age ≥ 18 years * Confirmed diagnosis of RRMM * Received one to three prior therapies * Planning to receive elotuzumab in combination with lenalidomide and dexamethasone at physician's medical judgement
Exclusion criteria
* Participants with therapeutic indications for which elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone has not been approved in Taiwan * Participants who are contraindicated for treated with elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone (as described in the Taiwan label) * Participants who participate in other interventional clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | Assessed according to NCI CTCAE v5.0 |
| Number of participants with adverse events of special interest | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | Opportunistic infections including viral hepatitis and tuberculosis reactivation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with other viral infection/reactivation | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | — |
| Number of participants with tuberculosis infection/reactivation | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | — |
| Number of participants with fungal infections | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | — |
| Number of participants with lymphopenia | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | Laboratory abnormality and/or adverse event |
| Number of participants with other opportunistic infections | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | — |
| Number of participants with reactivation of viral hepatitis | 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date) | — |
Countries
Taiwan
Outcome results
None listed