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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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