Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.
The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed through screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specimen Collection |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample of Blood | Other | Collection of blood sample from participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression (TTP) from MGUS/SMM to overt multiple myeloma. | Progression to symptomatic multiple myeloma | 15 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
* • Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy.
• Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia
First-degree relatives would not need to be identified by the participant.
This study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.
Not provided
Not provided
Not provided
All special populations who fall within the eligible high-risk age range, ≥ 30 years of age are included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Ghobrial, MD | Contact | 617-632-4198 | promisestudy@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Irene Ghobrial, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39571144 | Derived | Bertamini L, Alberge JB, Lee DJ, El-Khoury H, Kim S, Fleming G, Murphy C, Colchie J, Davis MI, Perry J, Lightbody ED, Allam S, Goqwana LN, Philip V, Smyth N, Sakrikar D, Perkins M, Harding S, Troske D, Getz G, Karlson EW, Munshi N, Anderson KC, Trippa L, Marinac CR, Chen WC, Joffe M, Ghobrial IM. Serum free light chains in a racially diverse population including African Americans and populations from South Africa. Blood. 2025 Feb 20;145(8):840-849. doi: 10.1182/blood.2024026078. | |
| 38212245 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
We collect blood samples from participants to test for precursor conditions to multiple myeloma.
| Derived |
| Lee DJ, El-Khoury H, Tramontano AC, Alberge JB, Perry J, Davis MI, Horowitz E, Redd R, Sakrikar D, Barnidge D, Perkins MC, Harding S, Mucci L, Rebbeck TR, Ghobrial IM, Marinac CR. Mass spectrometry-detected MGUS is associated with obesity and other novel modifiable risk factors in a high-risk population. Blood Adv. 2024 Apr 9;8(7):1737-1746. doi: 10.1182/bloodadvances.2023010843. |
| 35344689 | Derived | El-Khoury H, Lee DJ, Alberge JB, Redd R, Cea-Curry CJ, Perry J, Barr H, Murphy C, Sakrikar D, Barnidge D, Bustoros M, Leblebjian H, Cowan A, Davis MI, Amstutz J, Boehner CJ, Lightbody ED, Sklavenitis-Pistofidis R, Perkins MC, Harding S, Mo CC, Kapoor P, Mikhael J, Borrello IM, Fonseca R, Weiss ST, Karlson E, Trippa L, Rebbeck TR, Getz G, Marinac CR, Ghobrial IM. Prevalence of monoclonal gammopathies and clinical outcomes in a high-risk US population screened by mass spectrometry: a multicentre cohort study. Lancet Haematol. 2022 May;9(5):e340-e349. doi: 10.1016/S2352-3026(22)00069-2. Epub 2022 Mar 25. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |