Last updated: 02/16/2023 04:20:36
B-cell maturation antigen (BCMA) European Union (EU) historic control arm or study
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Retrospective cohort of relapsing/refractory multiple myeloma (RRMM) patients, treated in terms of clinical practice, who have received at least three prior lines of anti-myeloma therapy to be compared with patients enrolled in GSK’s clinical trial NCT03525678 of GSK2857916 medicine (BCMA) in France, Germany, Italy, Spain, and the UK
Trial description: The objective of the study is to generate a European based historical cohort of subjects treated by anti-myeloma agents according to local standard of care (SoC) and provide an external comparative assessment with the DREAMM 2 study [NCT03525678] of GSK2857916. Subjects included will have the same characteristics as those included in GSK’s DREAMM 2 study. The historical cohort has two sub-cohorts: external control cohort and descriptive cohort where subjects receiving active treatment and best supportive care (BSC) for RRMM will be included, respectively. Outcomes of the external control cohort will be compared to the DREAMM 2 study outcomes. This is a multi-country, multi-site, retrospective observational chart review study which includes data collected from index date to date of data collection (latest 31st August 2019), death or loss of follow-up. The index date is defined as the date of initiation of fourth or later lines of therapy in subjects receiving an active treatment or date of progression after 3rd line therapy in subjects receiving BSC. During historical cohort window period, if the subject initiates several lines of therapy, the most recent line of therapy will be considered as index date.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with overall response rate (ORR)
Timeframe: Approximately 9 months
Number of subjects with clinical benefit rate (CBR)
Timeframe: Approximately 9 months
Duration of response (DOR)
Timeframe: Approximately 9 months
Time to response (TTR)
Timeframe: Approximately 9 months
Progression-free survival (PFS)
Timeframe: Approximately 9 months
Overall survival (OS)
Timeframe: Approximately 9 months
Number of subjects with abnormal hematology parameters
Timeframe: Approximately 9 months
Number of subjects with abnormal clinical chemistry parameters
Timeframe: Approximately 9 months
Number of subjects reporting adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
Timeframe: Approximately 9 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-31-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
IQVIA
Study date(s)
August 2019 to July 2020
Type
Observational
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or female, 18 years or older, at index date.
- Eastern Cooperative Oncology Group (ECOG) performance 0-2 at index date. If ECOG is not available, Karnofsky scale can be used (performance 60-100 at index date, +/-7 days).
- Known symptomatic amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, skin changes (POEMS, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or active plasma cell leukemia at index date.
- Prior allogeneic stem cell transplant of autologous stem cell transplant <=100 days prior to the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female, 18 years or older, at index date.
- Eastern Cooperative Oncology Group (ECOG) performance 0-2 at index date. If ECOG is not available, Karnofsky scale can be used (performance 60-100 at index date, +/-7 days).
- Histologically or cytologically confirmed diagnosis of MM as defined according to International Myeloma Working Group, at any point in their medical chart.
- Undergone stem cell transplant or is considered transplant ineligible.
- Has failed at least 3 prior lines of anti-myeloma treatments, including anti CD38 mAbs e.g., daratumumab) alone or in combination, and is refractory to IMID (i.e., lenalidomide or pomalidomide), and to a PI (i.e., bortezomib, ixazomib or carfilzomib), and has started treatment with a fourth or later line of therapy or BSC.
- Measurable disease with at least one of the following: serum M-protein >=0.5 gram per deciliter (g/dL) (>=5 gram per Liter [g/L]); urine M-protein >=200 milligram per 24 hours (mg/24h); serum free light chain (FLC) assay: involved FLC level >=10 milligram per deciliter (mg/dL) (>=100 milligram per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or >1.65).
- Availability of full MM clinical chart at the participant site.
Exclusion criteria:
- Known symptomatic amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, skin changes (POEMS, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or active plasma cell leukemia at index date.
- Prior allogeneic stem cell transplant of autologous stem cell transplant <=100 days prior to the index date.
- Evidence of active mucosal or internal bleeding at index date.
- A body cavity was entered
- A mesenchymal barrier was crossed
- An organ was removed
- Subjects with at least one know inadequate organ system function at index date (+/-7 days) as defined as follows: absolute neutrophil count <1.0 times 10^9/L; hemoglobin <8.0 g/dL; platelets <50 times 10^9/L; total bilirubin >1.5 times upper limit of normal (ULN) (isolated bilirubin >=1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); alanine aminotransferase >2.5 times ULN; estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/m^2); spot urine (albumin/creatinine ratios [spot urine]) >=500 milligram per gram (mg/g) (56 mg per millimoles [mg/mmol]); or left ventricular ejection fraction (LVEF) < 45 percent.
- Presence of a known active renal condition (infection, requirement for dialysis) at index date. Subjects with isolated proteinuria resulting from MM are eligible.
- Unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy at index date is acceptable.
- Other malignancies than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years before the index date. Non-melanoma skin malignancies resected in <2 years ago are allowed.
- Known active infection requiring antibiotic, antiviral, or antifungal treatment at index date.
- Known human Immunodeficiency Virus (HIV) infection at index date.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) within 3 months prior to the index date.
- Positive hepatitis C antibody test result 3 months prior to the index date.
- Known evidence of cardiovascular risk including: history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months before index date; Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA); uncontrolled hypertension at index date.
Any major surgery within the last four weeks prior to the index date, defined as any invasive operative procedure where one or more of the following occurred:
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2020-31-07
Actual study completion date
2020-31-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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