| CTRI Number |
CTRI/2026/02/103522 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [High Fibre Dietary Intervention] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of a high-fibre diet on disease remission in newly diagnosed multiple myeloma patients |
|
Scientific Title of Study
|
Feasibility of high fibre dietary intervention in newly diagnosed Multiple Myeloma patients and its effect on gut microbiome and disease remission. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna K Yathi |
| Designation |
Scientist C |
| Affiliation |
Amala Institute of Medical sciences |
| Address |
Department of Medical Oncology
Molecular Oncology Laboratory Division
Room No. 25, 1st Floor
Amala Cancer Research Centre Block
Amala Institute of Medical Sciences
Thrissur
Kerala
India
Thrissur KERALA 680555 India |
| Phone |
8921282419 |
| Fax |
|
| Email |
krishnayathy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sreeraj V |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical sciences |
| Address |
Department of Clinical Hematology
Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Thrissur KERALA 680555 India |
| Phone |
8826752985 |
| Fax |
|
| Email |
sreerajfleming@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sreeraj V |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical sciences |
| Address |
Department of Clinical Hematology
Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Thrissur KERALA 680555 India |
| Phone |
8826752985 |
| Fax |
|
| Email |
sreerajfleming@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Kerala
India
680555 |
|
|
Primary Sponsor
|
| Name |
Amala Institute of Medical Sciences |
| Address |
Department of Molecular Oncology Laboratory
Amala Nagar
P.O Thrissur
Pin 680555 |
| Type of Sponsor |
Other [Charitable Trust] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna K Yathi |
Amala Institute of Medical Sciences |
Department of Medical Oncology
Molecular Oncology Laboratory Division
Room No. 25, 1st Floor
Amala Cancer Research Centre Block
Amala Institute of Medical Sciences
Thrissur, Kerala, India Thrissur KERALA |
8921282419
krishnayathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C900||Multiple myeloma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
high fibre dietary intervention in newly diagnosed Multiple Myeloma patients |
Stool samples collected at baseline and 4 months post chemotherapy |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed Multiple Myeloma patients
Aged 18 to 60 years
Who will be treated with Lenalidomide/Bortezomib/Dexamethasone induction [VLD] chemotherapy.
|
|
| ExclusionCriteria |
| Details |
Relapsed Multiple Myeloma
Patient with inflammatory bowel disease or other contraindications for a high-fibre diet
Multiple Myeloma with renal failure at diagnosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analysis of the change in gut microbiota composition from baseline after the introduction of a high
fibre diet in patients with multiple myeloma receiving induction chemotherapy.
Taxonomic classification and relative abundance of the butyrate-producing gut microbiota from baseline to myeloma patients with post high fibre-rich diet undergoing chemotherapy
Mean change in stool microbiome alpha diversity from baseline after 4 months of high fibre diet
Mean change in butrate producers individually and in total-Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria(4) after 4 months of high fibre diet from the baseline.
Percentage of people with relative abundance of firmicutes, actinobacteria, bacteroidetes, and fusobacteria at the end of 4 months of high fibre diet from the baseline.
|
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tolerability and acceptability to the high fibre diet measured by
Percentage of days where diet recommendations were followed
Percentage of patients with high GI symptoms score with respect to patient reported GI symptoms scoring based on the GSRS questionnaire done weekly
Percentage of patients with good satisfaction and acceptance based on patient reported diet tolerability and acceptance based on the 45 item Diet Satisfaction Questionnaire done monthly
Average daily fibre intake as assessed by a dietician based on diet diary
Percentage of emergency visits with GI symptoms and frequency of emergency visits.
Percentage of grade 3 or grade 4 adverse events as measured weekly.
|
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multiple myeloma is a common hematological malignancy that is usually treated with chemotherapy and immunomodulatory drugs such as Lenalidomide. In India, patients and their families often attempt dietary modification after a cancer diagnosis, influenced by traditional practices including Ayurveda. However, typical Indian diets, although predominantly plant-based, frequently do not provide adequate dietary fibre, which is important for maintaining a healthy gut microbiome. The human gut microbiome plays a crucial role in immune regulation and cancer treatment response, and its composition can be modulated by dietary intake; high-fibre diets modulate the gut microbiome, increasing the abundance of butyrate-producing bacterial species, which have anti-inflammatory and immunomodulatory effects and are associated with improved outcomes, including minimal residual disease (MRD) negativity in multiple myeloma. This study aims to assess the feasibility of a high fibre-rich diet during initial treatment of multiple myeloma and to determine whether the intervention is tolerable and influences response to standard induction chemotherapy. Patients receiving standard induction therapy with Lenalidomide, Bortezomib, and Dexamethasone will follow a high-fibre, plant-based diet using locally available foods, and the impact of this intervention on the gut microbiome will be assessed through stool samples collected at baseline and at the end of induction therapy. Patient gastrointestinal symptoms, dietary adherence, and clinical response will be assessed at baseline and at the end of induction therapy to evaluate both the tolerability of the diet and its potential influence on treatment outcomes.If the high-fibre dietary intervention is feasible and well tolerated, it will be further evaluated in combination with chemotherapy in future phase II and phase III clinical trials to assess its potential impact on gut microbiome modulation and treatment outcomes. |