Description:
This is a prospective, non-interventional, observational study. The purpose of this study is
to collect data and bio-specimens that will support future research
Title
- Brief Title: Collection of Specimens and Clinical Data to Create A Bio-repository for Multiple Myeloma
- Official Title: Collection of Specimens and Clinical Data to Create A Bio-repository for the Multiple Myeloma Program: The Indiana Multiple Myeloma Biobank
Clinical Trial IDs
- ORG STUDY ID:
IUSCC-0661
- NCT ID:
NCT03616483
Conditions
Purpose
This is a prospective, non-interventional, observational study. The purpose of this study is
to collect data and bio-specimens that will support future research
Trial Arms
Name | Type | Description | Interventions |
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Eligibility Criteria
Inclusion Criteria:
1. Male or female patients ≥ 18 years of age at the time of informed consent
2. Has been diagnosed with or is suspected to have one of the following:
1. Monoclonal Gammopathy of Undetermined Significance (MGUS)
2. Smoldering Multiple Myeloma
3. Multiple Myeloma
4. Bony or Soft Tissue Plasmacytoma
5. Primary Amyloidosis
Exclusion Criteria:
< 18 years of age
Have not been diagnosed with one of the following:
Monoclonal Gammopathy of Undetermined Significance (MGUS) b.Smoldering Multiple Myeloma
c.Multiple Myeloma d.Bony or Soft Tissue Plasmacytoma e.Primary Amyloidosis
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Create a repository |
Time Frame: | 5 years |
Safety Issue: | |
Description: | The primary objective of this study is to provide a mechanism to store comprehensive clinical, genomic, demographic, social, environmental and quality of life data from subjects with plasma cell dyscrasias |
Secondary Outcome Measures
Measure: | Data collection |
Time Frame: | 5 years |
Safety Issue: | |
Description: | To collect data related to clonal evolution, tumor microenvironment, clinical outcomes, adverse events, environmental factors and quality of life that will provide the foundation to create hypotheses for future confirmatory studies. |
Details
Phase: | |
Primary Purpose: | Observational |
Overall Status: | Recruiting |
Lead Sponsor: | Indiana University |
Trial Keywords
- Multiple myeloma
- Monoclonal gammopathy of undetermined significance
- Plasmacytoma
- Smoldering multiple myeloma
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