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CTRI Number  CTRI/2024/02/063266 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants with Relapsed or Refractory Myeloma who Have Received an Anti-CD38 Antibody and Lenalidomide 
Scientific Title of Study   A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide 
Trial Acronym  MonumenTAL-6 
Secondary IDs if Any  
Secondary ID  Identifier 
64407564MMY3009 AMENDMENT 1 14 July 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanish Davis 
Designation  R and D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. 
Address  Johnson and Johnson Private Limited, Arena Space Jogeshwari East.

Mumbai
MAHARASHTRA
400060
India 
Phone  919820958943  
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanish Davis 
Designation  R and D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. 
Address  Johnson and Johnson Private Limited, Arena Space Jogeshwari East.


MAHARASHTRA
400060
India 
Phone  919820958943  
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanish Davis 
Designation  R and D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd. 
Address  Johnson and Johnson Private Limited, Arena Space Jogeshwari East.


MAHARASHTRA
400060
India 
Phone  919820958943  
Fax    
Email  sdavis20@its.jnj.com  
 
Source of Monetary or Material Support  
Johnson and Johnson Private Limited Arena Space Jogeshwari East Mumbai MAHARASHTRA 
 
Primary Sponsor  
Name  Johnson and Johnson Private Limited  
Address  L. B. S. Marg, Mulund West Maharashtra, India 400080 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hungary
India
Italy
Japan
Netherlands
Poland
Republic of Korea
Saudi Arabia
Spain
Sweden
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sameer Melinkari  Deenanath Mangeshkar Hospital and Research Centre  Room no 101, 1st floor, Annex Building, Near Mhatre Bridge, Earndwane, Pune - 411004 Maharashtra, India.
Pune
MAHARASHTRA 		 9766249644

docmelinkeri@yahoo.com 
Dr Rahul Bhargava  Fortis Memorial Research Institute  UG floor, Department of Haematology, Fortis memorial research Institute, Sector - 44, Opposite HUDA City Centre, Oncology Dept., Gurgaon - 122002, Haryana, India
Gurgaon
HARYANA 		 9958174994

bhargava777@gmail.com 
Dr Sanjeev Yadav  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Administrative Block -1st floor, Room No. 205, New PMSSY Road, Rae Bareli Road, Lucknow - 226014, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 9670187769

dr.sanjeev.ranchi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics committee Deenanath Mangeshkar Hospital And Research Centre  Approved 
Institutional Ethics committee Fortis Memorial Resaerch Institute  Approved 
Institutional Ethics committee Sanjay Gandhi Postgraduate Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C900||Multiple myeloma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)  Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally- 28 day cycle; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally 21 day cycle as per investigator choice. Dexamethasone will be administered as a pretreatment medication. 
Intervention  Talquetamab + Pomalidomide (Tal-P)  Participants will receive talquetamab as subcutaneous (SC) injections - 28 days as per cycle; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. 
Intervention  Talquetamab + Teclistamab (Tal-Tec)  Participants will receive teclistamab in combination with talquetamab both as SC injection - 28 days as per cycle; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  -Documented multiple myeloma as defined by the criteria below:
a. multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
b. measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to greater than equal to 0.5 gram per deciliter; or (ii) urine M-protein level greater than equal 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain (FLC) greater than equal 10 milligrams per deciliter and abnormal serum Ig kappa lambda FLC ratio
-Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than 60 days after cessation of treatment. b) Refractory disease is defined as less than 25 percent reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to 60 days after cessation of treatment
- Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen- Have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
-A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment 
 
ExclusionCriteria 
Details 
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A maximum cumulative dose of corticosteroids of greater than equal 140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Progression Free Survival (PFS)  Up to 7 years 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Response Rate (ORR)  Up to 7 years 2 months 
Complete Response (CR) or Better Rate  Up to 7 years 2 months 
Very Good Partial Response (VGPR) or Better Rate  Up to 7 years 2 months 
Minimal Residual Disease (MRD)-negative CR Rate  Up to 7 years 2 months 
Overall Survival (OS)  Up to 7 years 2 months 
Progression Free Survival on Next-line Therapy (PFS2)  Up to 7 years 2 months 
Time to Next Treatment (TTNT)  Up to 7 years 2 months 
Serum Concentration of Talquetamab and Teclistamab  p to 7 years 2 months 
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab  Up to 7 years 2 months 
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)  Up to 7 years 2 months 
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30  Up to 7 years 2 months 
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)  Up to 7 years 2 months 
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression –Severity (PGI-S)  Up to 7 years 2 months 
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey  Up to 7 years 2 months 
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q  Up to 7 years 2 months 
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30  Up to 7 years 2 months 
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L  Up to 7 years 2 months 
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S  Up to 7 years 2 months 
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste SurveyChange from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey  Up to 7 years 2 months 
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30  Up to 7 years 2 months 
 
Target Sample Size   Total Sample Size="795"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   07/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="7"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd). 
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