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| Name | Class |
|---|---|
| Blood Cancer United | OTHER |
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The purpose of the study is to find out whether a dietary intervention can affect treatment response and/or quality of life for people with newly diagnosed multiple myeloma receiving standard induction chemotherapy with daratumumab (or isatuximab), lenalidomide, bortezomib, and dexamethasone (DRVd). The researchers will measure quality of life by having participants complete questionnaires. The study will investigate the effects of diet on quality of life, treatment response, and other disease, microbiome, and immune markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care (UC) | Active Comparator | Usual care (UC) While receiving standard induction chemotherapy as part of routine care, participants will have phone calls with a member of the study team every 4 weeks. At the end of standard induction chemotherapy, participants will have a phone call or video call with a dietitian. |
|
| Intervention arm | Experimental | While receiving standard induction chemotherapy as part of routine care,participants will have a phone call or video call with a dietitian every 2 weeks for 12 weeks and will receive high-fiber plant-based meals for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition counseling and coaching | Other | In addition to individual counseling, patients will be able to join optional group sessions every 2 weeks as well as text message check-ins for survey completion reminders. Patients will receive 12 frozen, fixed pre-made lunch and dinner shipped to their home weekly from Modify Health for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal residual disease negative complete response (MRD-CR) rate | rates by IMWG criteria | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| compare the rates of improvement in QOL | global health status per EORTC QLQ C30 survey administration | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Urvi A Shah, MD, MS | Contact | 646-608-3713 | ShahNutrivention@mskcc.org | |
| Carlyn Rose Tan, MD | Contact | 646-608-3778 |
| Name | Affiliation | Role |
|---|---|---|
| Urvi A Shah, MD, MS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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This is a nontherapeutic study testing a high fiber plant based dietary intervention.
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|
| dietary guidelines, research dietitian visit | Other | Participants will have phone calls with a member of the study team every 4 weeks as well as text message check-ins for survey completion reminders. At the end of standard induction chemotherapy, participants will have a phone call or video call with a dietitian |
|
| Questionnaires | Behavioral | Block FFQ survey, EORTC QLQ C30 survey, EORTC MY20 survey, Pre intervention survey, Post intervention survey |
|
| Frozen pre-prepared meals | Other | Patients will receive 12 frozen, fixed pre-made lunch and dinner shipped to their home weekly from Modify Health for 12 weeks. |
|
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting | Uniondale | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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| ID | Term |
|---|---|
| D018673 | Nutrition Policy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D006291 | Health Policy |
| D011640 | Public Policy |
| D011049 | Social Control Policies |
| D057766 | Policy |
| D004472 | Health Care Economics and Organizations |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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