ClinicalTrials.gg
Not yet recruitingNCT07932301PREPAREUpdated Nov 12, 2026

Pre-Transplant Nutrition Counseling in Patients With Multiple Myeloma

An interventional study of Pre-HSCT Nutrition Counseling and Usual Care in Multiple Myeloma, sponsored by University of Utah. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Utah · Not applicable, Interventional, and Supportive care

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,168 studies in Multiple Myeloma with a site in United States — 276 open to participants now, 503 under way, 66 of them phase 3. Multiple Myeloma · United States.

Planned enrollment
1,308th of 1,901
20 · median 36
Started
2026
with 75 others
No phase
179 of 2,168
30 open now
Primary completion
2028-06
later than 351 of 499 live
Registered
2,168th of 2,168
by date

Among the 2,168 studies in Multiple Myeloma with a site in United States, this one is the 1,308th largest by planned enrollment of the 1,901 interventional ones that give a count, is one of 76 that started in 2026, is one of 179 with no phase, reaches primary completion later than 351 of the 499 other live ones, and was the 2,168th registered.

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

276 of the 2,168 studies in Multiple Myeloma with a site in United States are open now. Recruiting first, the newest first:

271 more — sign in →

All 276 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,168 studies in Multiple Myeloma with a site in United States, or all of them as a file.
02

Study summary

The primary endpoint of this pilot randomized controlled trial (RCT) will evaluate the feasibility and acceptability of an 8-week pre-hematopoietic stem cell transplant (HSCT) nutrition counseling intervention aimed at improving dietary intake and quality before HSCT to attenuate post-HSCT malnutrition among up to 20 patients with multiple myeloma (MM).

Hypothesis: An 8-week pre-transplant nutrition counseling intervention will be feasible and acceptable among patients with MM undergoing HSCT.

Read the detailed description

Hematopoietic Stem Cell Transplantation (HSCT) is standard of care for multiple myeloma (MM), yet treatment-related toxicities result in post-transplant malnutrition in up to 80% of patients. Conditioning chemotherapy is associated with substantial toxicities, including severe nausea, vomiting, and mucositis, which impair oral intake and disrupt GI function. Peri-transplant malnutrition is associated with increased healthcare utilization, higher infection risk, greater incidence of mucositis, reduced quality of life (QOL), and worse survival.

This pilot, parallel-group randomized controlled trial evaluates the feasibility and acceptability of an 8-week nutrition counseling intervention designed to improve dietary intake and quality among 20 patients with MM undergoing HSCT (1:1 allocation). Counseling begins at the start of induction therapy and continues for 8 weeks through weekly 30-45 minute video sessions delivered by a registered dietitian. The intervention utilizes stepwise, incremental goals targeting energy intake, protein intake, and fruit/vegetable consumption, monitored via a dietary tracking application. Control participants receive usual standard of care, including written educational materials and one pre-HSCT dietitian consultation 2-3 weeks prior to HSCT to discuss anticipated side effects.

PRIMARY OBJECTIVES I. Conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of an 8-week pre-hematopoietic stem cell transplant (HSCT) nutrition counseling intervention aimed at improving dietary intake and quality before HSCT to attenuate post-HSCT malnutrition among up to 20 patients with multiple myeloma (MM).

EXPLORATORY OBJECTIVES I. Leverage the usual-care control arm to characterize longitudinal changes in protein and energy intake, diet quality, malnutrition risk and status, physical activity, and quality of life from baseline (post-diagnosis, pre-induction therapy) through approximately three weeks post-HSCT to inform refinement of intervention timing, duration, and outcome assessment.

II. Compare the sensitivity and specificity of recommended malnutrition screening tools relative to a validated malnutrition assessment tool to inform selection of the optimal screening tool for patients with multiple myeloma.

III. Estimate the effect of the intervention, compared with usual care, on post-HSCT malnutrition status to inform the design of a larger, adequately powered trial.

03

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Nutrition Counseling
  • Registered Dietitian Nutritionist
  • Malnutrition
  • Diet Quality
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject age >= 18 years old
  • Individuals newly diagnosed with multiple myeloma undergoing hematopoietic stem cell transplantation as part of therapy
  • Willingness to engage in virtual nutrition counseling intervention one day per week for eight weeks if assigned to the nutrition counseling group
  • Willingness to complete 1-3 food records using Cronometer dietary tracking app each week for eight weeks if assigned to the nutrition counseling group
  • Willingness to complete four virtual assessment sessions (baseline, post-intervention, pre-, post-HSCT)
  • Able to provide and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion criteria

Exclusion Criteria:

  • Patients with multiple myeloma for whom hematopoietic stem cell transplantation is not planned
  • Patients who do not speak English will be excluded for this pilot trial due to inadequate funds and staffing to successfully execute this trial in languages other than English
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Nutrition Counseling Intervention

    8-week pre-HSCT virtual nutrition counseling intervention (1 session per week, 30-45 minutes) delivered by a registered dietitian and completion of 1-3 weekly dietary tracking a dietary tracking application.

    Behavioral: Pre-HSCT Nutrition Counseling

  • Active comparator
    Usual Care

    Standard clinical care including AICR educational booklet provided on Cycle 1 Day 1 of induction therapy and standard pre-HSCT dietitian consultation 2-3 weeks prior to transplant.

    Other: Usual Care

Interventions

  • BehavioralPre-HSCT Nutrition Counseling

    Participants receive one 30-45 minute virtual nutrition counseling session per week for 8 weeks starting on or within 7 days after Cycle 1 Day 1 of induction therapy. Sessions are delivered by a registered dietitian using the Nutrition Care Process framework with stepwise goal setting targeting energy, protein, and fruit/vegetable intake based on food records tracked via a dietary tracking application.

  • OtherUsual Care

    Participants receive standard medical care, including the American Institute for Cancer Research (AICR) Living with Cancer handbook on Cycle 1 Day 1 of induction therapy and a standard dietitian consultation 2-3 weeks prior to HSCT regarding expected treatment side effects.

06

What researchers measure

Primary outcomes

  1. Intervention Feasibility

    Feasibility is defined as: (1) \>=40% enrollment rate among potentially eligible patients, (2) \>=70% completion of the 8-week intervention, and (3) \>=70% attendance of \>=75% of scheduled counseling sessions (\>=6 sessions) and completion of \>=1 food record per week.

    Time frame: End of 8-week intervention (Week 9)

  2. Intervention Acceptability

    Acceptability assessed using an end-of-intervention survey completed by intervention participants. Considered acceptable if \>=80% of all agreement-based responses are "Agree" or "Strongly agree".

    Time frame: End of 8-week intervention (Week 9)

Secondary outcomes

  1. Global Leadership Initiative on Malnutrition (GLIM)

    Malnutrition status will be assessed according to the GLIM criteria. A malnutrition diagnosis requires at least one etiologic criterion (reduced food intake or assimilation and/or disease burden or inflammation) and at least one phenotypic criterion (weight loss, low body mass index, and/or reduced muscle mass) are present. Severity is graded as moderate or severe based on the phenotypic criteria.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)]

  2. Malnutrition Screening Tool (MST)

    The Malnutrition Screening Tool (MST) is a two-question screening tool that assesses malnutrition risk. Scores range from 0-5. Scores \>=2 indicate malnutrition risk, whereas scores \<2 indicate no risk.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  3. NUTRISCORE

    NUTRISCORE includes the MST questions and additional items related to cancer site and anticancer treatment. Scores range from 0 to 11; scores ≥5 indicate malnutrition risk, whereas scores \<5 indicate no malnutrition risk.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  4. Malnutrition Universal Screening Tool (MUST)

    The MUST assesses BMI, unintentional weight loss, and the acute disease effect. Scores range from 0 to 6. A score of 0 indicates low risk of malnutrition, 1 indicates medium risk, and scores ≥2 indicate high risk of malnutrition.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  5. Mini Nutritional Assessment-Short Form (MNA-SF)

    The MNA-SF is a six-item screening tool used to assess nutritional status in older adults. Scores range from 0 to 14; scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnutrition.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  6. Nutrition Risk Screening 2002 (NRS-2002)

    The NRS-2002 assesses impaired nutritional status, disease severity, and age. Scores range from 0 to 7; scores ≥3 indicate nutritional risk, whereas scores \<3 indicate no nutritional risk.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  7. Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF)

    The PG-SGA SF is a four-item, patient-completed nutrition screening tool assessing weight history, food intake, nutrition impact symptoms, and activity and function. Scores range from 0-36. A score ≥7 indicates malnutrition risk.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  8. Protein intake

    Average daily protein intake, measured in grams per day, will be calculated from 1-3-day food records collected using a dietary tracking application.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  9. Energy intake

    Average daily energy intake, measured in kilocalories per day, will be calculated from 1-3-day food records collected using a dietary tracking application.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  10. Godin Leisure-Time Exercise Questionnaire.

    Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. The Leisure Score Index is calculated by weighting the weekly frequency of strenuous, moderate, and mild activity by 9, 5, and 3 metabolic equivalents, respectively, and summing the weighted values. Scores have no fixed upper limit; higher scores indicate greater leisure-time physical activity.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  11. Mini Eating Assessment Tool (mini-EAT)

    The Mini-EAT is a nine-item dietary screener that assesses diet quality. Scores range from 0 to 100, with lower scores indicating poorer diet quality and higher scores indicating better diet quality.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

  12. European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a 30-item questionnaire that assesses global health status/QOL, physical, role, emotional, cognitive, and social functioning, and cancer-related symptoms. All scale scores range from 0 to 100. Higher global health status/QOL and functioning scores indicate better QOL and functioning, whereas higher symptom scores indicate greater symptom burden.

    Time frame: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

Of 172 non-industry interventional studies with no phase under Multiple Myeloma, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 81. This study's planned 18 months is below that.

Counting every sponsor, half of 186 studies reached it within 38 months; a quarter within 20 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartEst.
Dec 2026
Primary completionEst.
Jun 2028
CompletionEst.
Dec 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07932301
Lead sponsor
University of Utah
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Adriana Coletta, MD
Contact
adriana.coletta@hci.utah.edu
801-213-6012
Rachel Hoobler
Contact
rachel.hoobler@hci.utah.edu
801-646-9800
Adriana Coletta, MD
principal investigator · Huntsman Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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