Multiple Myeloma
Conditions
Keywords
Myeloma, Multiple Myeloma, Observational, Longitudinal
Brief summary
The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.
Detailed description
Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.
Interventions
None listed
Sponsors
Translational Genomics Research Institute
Corewell Health West
Van Andel Research Institute
Multiple Myeloma Research Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old. * Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following: Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (\<0.26 or \>1.65). * The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen. * No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy. * Patient has read, understood and signed informed consent.
Exclusion criteria
* Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study). * Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix). * Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease. | Baseline to 8 years. | Standard clinical and laboratory assessments. Genomic tests (DNA and RNA sequencing, etc.) on bone marrow aspirates obtained at baseline, suspected complete response, and relapse/progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rates | Five to eight years after baseline | Progression-free survival and overall survival |
| Bone disease assessed radiographically | Baseline and during five to eight years of follow-up | — |
| Response rates | Up to one year after baseline. | IMWG criteria: stringent complete response, complete response, very good partial response, partial response, no response. |
| Resource utilization | Baseline and during five to eight years of follow-up | Hospitalizations and ER visits |
| Severe adverse events | Five to eight years | Severe/CTCAE grade 3-4 adverse events (checklist) |
| Health-related quality of life | Baseline and during five to eight years of follow-up | EORTC QLQ-C30 and QLQ-MY20 |
Countries
Canada, Spain, United States
Outcome results
None listed