Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been newly diagnosed with multiple myeloma, confirmed by a bone marrow biopsy and specific laboratory and genetic tests.
• People aged 18 or older.
• People whose multiple myeloma has been found in the bone marrow.
• People whose treatment plan includes four 28-day rounds (cycles) of a specific four-drug chemotherapy combination involving daratumumab or isatuximab, lenalidomide, bortezomib, and a steroid such as dexamethasone.
• People for whom all four planned drugs have been started by the beginning of the second treatment cycle.
• People who enrol before day 21 of their first treatment cycle, as the study's additional treatment begins at the start of cycle two.
• People receiving treatment at a hospital or clinic where the treating cancer doctor is able and planning to test the bone marrow for signs of remaining cancer (using a highly sensitive method called next-generation sequencing) after the four cycles are finished (confirm with trial site).
• People receiving treatment at MSK or at a site that uses a specific electronic medical records system called EPIC, and where the site is willing to share records with MSK (confirm with trial site).
• People who are also enrolled in another trial that allows for the same four-cycle chemotherapy combination described above.
• People who have previously received dexamethasone treatment.
• People who have received up to one cycle of cyclophosphamide and/or bortezomib with dexamethasone to help control their disease before joining.
• People who are able to attend study visits and complete all required study activities.
• People taking GLP-1 medications (a type of drug sometimes used for diabetes or weight management), provided the medication was started at least three months before the second treatment cycle begins, or was started more recently specifically to manage diabetes rather than for weight loss.
• People whose caregiver or the person themselves is able to complete surveys as part of the study.
• People whose typical daily diet includes less than 30 grams of dietary fibre per day, based on a baseline dietary assessment.
• People who follow an ovo-lacto-vegetarian diet (which includes eggs and dairy) or a processed/junk food vegan diet are eligible, even if plant-based foods are included.

Who may not be able to join:

• People whose multiple myeloma has spread to the brain or the fluid surrounding the brain and spinal cord.
• People who have previously received certain intensive combination chemotherapy regimens, such as VDPACE or DCEP.
• People with a Body Mass Index (BMI) of 19 or below (a measure of body weight relative to height).
• People for whom the treating doctor has concerns about safety or any medical reasons that could prevent safe completion of the study (confirm with trial site).
• People with a severe allergy (such as a life-threatening reaction like anaphylaxis) to any legume (for example, beans, lentils, or chickpeas), allergies to several different legumes, or where cross-contamination with legumes poses a risk.
• People with a severe allergy, such as anaphylaxis, to peanuts and/or tree nuts such as cashews.
• People already enrolled in another study that requires a different treatment plan than the four-cycle chemotherapy combination described above.
• People currently participating in weight loss programs or dietary programs that require following a specific diet or taking weight loss supplements.
• People who have planned extended travel during the study that would make it impossible to follow the required diet as directed.

Important: Always verify eligibility with the trial site directly before applying.