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CTRI Number  CTRI/2023/08/056910 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) 
Scientific Title of Study   A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2022-500861-29-00  EudraCT 
File No. CT/23/000035  DCGI 
NCT05552976  ClinicalTrials.gov 
Protocol no: CA057008, Version 1 dated 10/Nov/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpi Sinha  
Designation  Head RCO- India 
Affiliation  Bristol Myers Squibb India Pvt. Ltd  
Address  one international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - India Bristol Myers Squibb India Pvt. Ltd

Mumbai
MAHARASHTRA
400013
India 
Phone  2266288645  
Fax  91-2266288645  
Email  Shilpi.Sinha@bms.com  
 
Details of Contact Person
Scientific Query  
Name  Shilpi Sinha  
Designation  Head RCO- India 
Affiliation  Bristol Myers Squibb India Pvt. Ltd  
Address  one international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - India Bristol Myers Squibb India Pvt. Ltd


MAHARASHTRA
400013
India 
Phone  2266288645  
Fax  91-2266288645  
Email  Shilpi.Sinha@bms.com  
 
Details of Contact Person
Public Query  
Name  Shilpi Sinha  
Designation  Head RCO- India 
Affiliation  Bristol Myers Squibb India Pvt. Ltd  
Address  one international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - India Bristol Myers Squibb India Pvt. Ltd


MAHARASHTRA
400013
India 
Phone  2266288645  
Fax  91-2266288645  
Email  Shilpi.Sinha@bms.com  
 
Source of Monetary or Material Support  
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED  
 
Primary Sponsor  
Name  BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED  
Address  BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - 400013 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     United States of America
Singapore
Spain
Taiwan
United Kingdom
Argentina
Australia
Austria
Brazil
Canada
Colombia
Denmark
Germany
Greece
Hong Kong
India
Italy
Netherlands
Norway  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SVSS Prasad  Apollo Hospitals, (A Unit of Apollo Hospitals Enterprises Limited)  ground floor, OPD of Dr SVSS Prasad, Apollo Cancer Institute
Hyderabad
TELANGANA 		 1204189500

svss.prasad@yahoo.co.in 
Dr Nikita Jagdish Mehra  Cancer Institute (W.I.A.)  Department of Medical Oncology, 3rd Floor, Bhagwan Mahaveer Visharanthi Graha
Chennai
TAMIL NADU 		 9884323933

nikita.mehra3@gmail.com 
Dr Nataraj K S  Healthcare Global Enterprises Ltd  Haematology Department, 4th Floor, Tower-1
Bangalore
KARNATAKA 		 9482141773

drnatarajks@gmail.com 
Dr Sachin Jadhav  Kamineni Gem Care Hospital  2nd floor OPD Consultation room Hematology and BMT L B Nagar Hyderabad 500068 Telangana India
Hyderabad
TELANGANA 		 9741351357

drsachinjadhav@hotmail.com 
Dr Gautam Goyal  Max Super Speciality Hospital, Mohali  A unit of Hometrail Buildtech Pvt. Ltd., Dept of Oncology and Oncosurgery, Near Civil hospital, Phase-6, Mohali, Punjab- 160055
Rupnagar
PUNJAB 		 08195849111

gautam3636@gmail.com 
Dr Nitin Sood  Medanta-The Medicity  Department of Medical Oncology and Haematology, Room No. 13, 10th Floor, OPD
Gurgaon
HARYANA 		 1244141414

Nitin.Sood@Medanta.org 
Dr Preetam Baban Kalaskar  Mumbai Oncocare Centre (Unit of cellcure cancer centre pvt Ltd)  1st Floor, OPD of preetam kalaskar, Blue Nile Building, , Near to Pinnacle Hospital
Thane
MAHARASHTRA 		 2225301090

drpritamkalaskar@mocindia.co.in 
Dr Pankaj Malhotra  Post Graduate Institute of Medical Education & Research, Nehru Hospital  Department of Haematology & Medical Oncology, Post Graduate Institute of Medical Education & Research, Nehru Hospital, 4th Floor, F Block
Chandigarh
CHANDIGARH 		 722755454

malhotrapankaj@hotmail.com 
Dr Narendra Agrawal  Rajiv Gandhi Cancer Institute and Research Centre  Hemato Oncology and Bone Marrow Transplant Room No 3265 2nd Floor
South
DELHI 		 1147022222

narendra_ag1@rediffmail.com 
Dr lingaraj Nayak  Tata Memorial Hospital (Tata Memorial centre)  Adult Haematolymphoid Room No. 81, Ground Floor, Main Building
Mumbai
MAHARASHTRA 		 2224177000

lingarajnayak86@gmail.com 
Dr Ganesh Shivlingrao Jaishetwar  Yashoda Super Speciality Hospital  Yashoda Super Speciality Hospital, Room No. 237, 2nd Floor
Hyderabad
TELANGANA 		 1204189500

ganeshjaishetwar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
HCG-Central Ethics Committee  Approved 
Institutional Ethics Committe Kamineni Hospitals  Approved 
Institutional Ethics Committee (IEC) Cancer Institute (W.I.A.)  Approved 
Institutional Ethics Committee Post Graduate Institute of Medical Education & Research,  Approved 
Institutional Ethics Committee, Max Super Speciality Hospital, Mohali, (A unit of Hometrail Buildtech Private Limited)  Approved 
Institutional Ethics Committee, Yashoda Academy of Medical Education and Research  Approved 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals  Approved 
Institutional Review Board, Rajiv Gandhi Cancer Institute & Research Centre,  Approved 
IRB-I, Tata Memorial Hospital  Approved 
Medanta Institutional Ethics Committee (MIEC)  Approved 
Mumbai Oncocare Centre- Cellcure cancer center Private Limited  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  Carfilzomib and Dexamethasone (Kd)  standard of care Carfilzomib (I/V infusion), and Dexamethasone (dose: 480Kd) thrice a month, per pack insert  
Intervention  CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd)  CC-92480 (BMS-986348) 0.3,0.6,1.0 mg capsule, once a day for 21day cycle, orally along with standard of care Carfilzomib (I/V infusion), and Dexamethasone (Dose: 480Kd) thrice as month, per pack insert 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ï‚· Participant has documented diagnosis of multiple myeloma (MM) and measurable disease,
defined as any of the following:
 M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or
 M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or,
 For participants without measurable disease in sPEP or uPEP: serum free light chain
(sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal κ/λ FLC ratio.
ï‚· Participant has received at least one prior line of anti-myeloma therapy. Note: One line can
contain several phases (eg, induction, [with or without] hematopoietic stem cell transplant,
(with or without) consolidation, and/or [with or without] maintenance therapy).
ï‚· Participant must have received prior treatment with lenalidomide and at least 2 cycles of an
anti-CD38 monoclonal antibody. Note: Patients who were intolerant of an anti-CD38 mAb and
received < 2 cycles are still eligible.
ï‚· Participant achieved minimal response [MR] or better to at least 1 prior anti-myeloma therapy.
ï‚· Participant must have documented disease progression during or after their last antimyeloma
regimen. 
 
ExclusionCriteria 
Details  1. Participant who has had prior treatment with CC-92480 or carfilzomib.
2. Participant has previously received allogeneic stem cell transplant at any time or received
autologous stem cell transplant within 12 weeks of initiating study treatment.
3. Participant has any of the following laboratory values at screening:
i. Absolute neutrophil count (ANC) < 1.0 × 109 /L (< 1,000/ μL) without growth factor
support within 7 days prior to screening complete blood count (CBC) (14 days if
pegfilgrastim is used)
ii. Platelets < 75 × 109 /L (< 75,000/μL) and no platelet transfusions within the 7-day period
leading up to screening CBC  Hemoglobin < 8 g/dL (< 4.9 mmol/L)
iii. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
iv. Estimated glomerular filtration rate (eGFR) < 30 mL/min or requiring dialysis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the progression free survival of
CC92480, carfilzomib & dexamethasone to that of carfilzomib and dexamethasone
in participants with relapsed or refractory multiple myeloma 		 at baseline, 8 Months and until Progression free survival up to 5 years or study achieves endpoints 
 
Secondary Outcome  
Outcome  TimePoints 
1. In Stage 1, to determine the dose of CC-92480 in
combination with carfilzomib & dexamethasone
to continue in Stage 2 of the study 		 at baseline, 24 weeks & 32 weeks 
2. In Stage 1, to determine the plasma concentrations
of CC-92480 in combination with carfilzomib and
dexamethasone 		 at baseline, 24 weeks & 32 weeks 
3 To compare overall survival (OS) between 480Kd
and Kd in participants with RRMM 		 at baseline, 24 weeks & 32 weeks 
4. To evaluate additional efficacy parameters in
participants with RRMM treated with 480Kd
compared to Kd 		 at baseline, 24 weeks & 32 weeks 
5. To evaluate additional efficacy parameters in
participants with RRMM treated with 480Kd compared to Kd 		 at baseline, 24 weeks & 32 weeks 
6. To evaluate additional efficacy parameters in
participants with RRMM treated with 480Kd compared to Kd 		 at baseline, 24 weeks & 32 weeks 
7. To evaluate additional efficacy parameters in
participants with RRMM treated with 480Kd
compared to Kd 		 at baseline, 24 weeks & 32 weeks 
8. To evaluate minimal residual disease (MRD)
negativity rate in participants treated with 480Kd compared to those treated with Kd 		 at baseline, 24 weeks & 32 weeks 
9. To evaluate safety of 480Kd compared to Kd in
participants with RRMM 		 at baseline, 24 weeks & 32 weeks 
10. In participants randomized to Stage 2 only, to evaluate cancer & multiple myeloma-related symptoms & health-related quality of life
(HRQoL) using the European Organization for
Research & Treatment of Cancer - Quality of Life
C30 questionnaire (EORTC QLQ-C30) & the
European Quality of Life Multiple Myeloma
module (EORTC QLQ-MY20) in participants
treated with 480Kd compared to Kd 		 at baseline, 24 weeks & 32 weeks 
 
Target Sample Size   Total Sample Size="525"
Sample Size from India="25" 
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)   03/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/09/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
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  
This study is a 2-stage, randomized, multicenter, open-label, Phase 3 study comparing the efficacy and safety of 480Kd versus Kd in participants with RRMM who received at least 1 prior line of therapy, including lenalidomide and an anti-CD38 mAb, however are carfilzomib naïve. Treatment will continue until confirmed PD, death, unacceptable toxicity, or withdrawal of consent. All participants will have an End of Treatment (EOT) visit to collect safety and efficacy assessments. Once the participant completes the end of treatment visit, they will enter the followup period.
 
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