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CTRI Number  CTRI/2020/06/025971 [Registered on: 18/06/2020] Trial Registered Prospectively
Last Modified On: 19/03/2021
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bioavailability study between Bortezomib for Injection 3.5 mg/0.2 mL and VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2  
Scientific Title of Study   An Open label, Multi-Centre, Randomized, Two-treatment, Multi dose, Parallel, Comparative Bioavailability Study of Bortezomib Injection 3.5 mg/0.2 ml and VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2 in Multiple Myeloma patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
P-727/18 Version No: 03 Dated by 13-JAN-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  P Veerendra Kumar 
Designation  Head - Clinical Affairs and Pharmacovigilance 
Affiliation  Shilpa Medicare Limited 
Address  S 20 to S 26, Pharma SEZ TSIIC, Green Industrial Park, Polepally Village, Jadcherla Mandal

Mahbubnagar
TELANGANA
509301
India 
Phone    
Fax    
Email  veerendrap.frd@shilpamedicare.com  
 
Details of Contact Person
Scientific Query  
Name  P Veerendra Kumar 
Designation  Head - Clinical Affairs and Pharmacovigilance 
Affiliation  Shilpa Medicare Limited 
Address  S 20 to S 26, Pharma SEZ TSIIC, Green Industrial Park, Polepally Village, Jadcherla Mandal

Mahbubnagar
TELANGANA
509301
India 
Phone    
Fax    
Email  veerendrap.frd@shilpamedicare.com  
 
Details of Contact Person
Public Query  
Name  P Veerendra Kumar 
Designation  Head - Clinical Affairs and Pharmacovigilance 
Affiliation  Shilpa Medicare Limited 
Address  S 20 to S 26, Pharma SEZ TSIIC, Green Industrial Park, Polepally Village, Jadcherla Mandal

Mahbubnagar
TELANGANA
509301
India 
Phone    
Fax    
Email  veerendrap.frd@shilpamedicare.com  
 
Source of Monetary or Material Support  
Shilpa Medicare Limited 
 
Primary Sponsor  
Name  Shilpa Medicare Limited  
Address  S-20 to S-26 Pharma SEZ TSIIC Green Industrial Park Polepally Village Jadcherala Mandal Mahaboobnagar District Telangana 509301 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 37  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashutosh Panigrahi  All India Institute of Medical Sciences  Patrapada, Bhubaneswar, Odisha-751019
Khordha
ORISSA 		 06742476789

medonco_ashutosh@aiimsbhubaneswar.edu.in 
Dr Amit Kumar Dhiman  Deep Hospital  481, Model Town, Ludhianna-141001,
Ludhiana
PUNJAB 		 9779898339

dramit.meet@gamil.com 
Dr Mukesh Chandre  Dhadiwal Hospital Incoaliation with Shreeji Healthcare  Opp. New CBS, Trimbak Road, Nashik-422002
Nashik
MAHARASHTRA 		 9595160424

mukeshchandre@gmail.com 
DrArchit Joshi  Gujrat Kidney & Superspeciality Hospital  NewIndiaMill Compound Nr Jetalpur Bridge, Jetalpur Rd, Vadodara, Gujarat 390020
Vadodara
GUJARAT 		 9662606944

archit_jsh@yahoo.co.in 
Dr Nilesh Wasekar  HCG Manavata Cancer Centre  Behind Shivang Auto, Mumbai Naka, Nashik-422002
Nashik
MAHARASHTRA 		 02536661111

nileshwasekar@gmail.com 
Dr Nishad Dhakate  HCG NCHRI Cancer Centre  Kashra No.50, 51 Mouja Wanjari, Bande Nawaz Nagar Automotive Square, Kalamna ring Road, -440026
Nagpur
MAHARASHTRA 		 07126711200

drnishaddhakate@hcgel.com 
Dr Susanta Kumar Paikaray  HCG Panda cancer hospital  NH-5, Telengapentha, Cuttack, Odisha 753051
Cuttack
ORISSA 		 06717116999

drskppgi@gmail.com 
Dr Koushik Chatterjee  Health Point Hospital  21, Prannath Pandit Street, Opposite of Lansdown Padmapukur, Kolkata- 700025
Kolkata
WEST BENGAL 		 06292206001

drkoushik.chatterjee@gmail.com 
Dr Pandidurai M  Hindu Mission Hospital  103, Grand Southern Trunk Rd, New Market, Tambaram West, Chennai, Tamil Nadu 600045
Chennai
TAMIL NADU 		 04422262244

pandi19@gmail.com 
Dr Priyanka Samal  Institute of Medical Sciences & SUM Hospital  K8, Kalinga Nagar, Ghatikia Bhubaneshwar, Odisha- 751 003
Khordha
ORISSA 		 06742386281

samal.priyanka80@gmail.com 
DrManoj Toshiwal  Ishwar Institute of Health Care  MH SH 16, Padegaon, Aurangabad, Maharashtra 431002
Aurangabad
MAHARASHTRA 		 9225300842

dr.manojtwal@gmail.com 
Dr Prateek Tiwari  Jawahar lal Nehru Cancer Hospital and Research centre  P13,No.32,Cancer Hospital Road, Idgah Hills,Bhopal
Bhopal
MADHYA PRADESH 		 9301135800

prateekmedonc@gamil.com 
Dr Rohan Bhise  KLES Dr. Prabhakar Kore Hospital & MRC  Nehrunagar Belagavi-590010 Karnataka India
Belgaum
KARNATAKA 		 08312493099

rohanbhise30@gmail.com 
Dr Abhijeet Ganapule  Kolhapur Cancer Centre Pvt. Ltd  R.S.238, Opp. Mayur Petrol Pump, Gokul Shirgaon, Kolhapur-416234.Maharashtra
Kolhapur
MAHARASHTRA 		 02312677991

abhiganapule@gmail.com 
Dr Ravi Wategaonkar  Lokmanya Hospital  314,Tilak Road,Chinchwad,Pune-411033
Pune
MAHARASHTRA 		 9823602626

rnwategaonkar@gmail.com 
Dr Riya Ballikar  Meditrina Institute of Medical Science   278, Central Bazar Road, Ramdaspeth, Nagpur-440010
Nagpur
MAHARASHTRA 		 07126669600

riabalikar@rediffmail.com 
Dr Kasi Viswanathan  Meenakshi Mission Hospital and Research Centre  Lake Area, Melur Road, Madurai-625107, Tamilnadu-India
Madurai
TAMIL NADU 		 04524263000

kasi.mmbro@gmail.com 
Dr P K Chaithanya  MNI Institute of Oncologist & Regional Cancer Centre  3rd Floor, Red Hills, Hyderabad-500004, Telangana
Hyderabad
TELANGANA 		 04023397000

mnjiorccchaithanya@gmail.com 
Dr Ashish Joshi  Mumbai Oncocare Centre   2nd Floor, Majithia Apartments, Gods Gift Premises Co-op Society Ltd, S.V. Road, Vile Parle (W)- 400056
Mumbai
MAHARASHTRA 		 9167009042

ashjoshi44@mocindia.co.in 
Dr Bodhisatta Roy  Netaji Subhash Chandra Bose Cancer Hospital  3081, Nayabad Main Rd, New Garia, Pancha Sayar
Kolkata
WEST BENGAL 		 9330766762

clinical.trial@nscri.in 
Dr Minish Jain  Noble Hospital Pvt. Ltd  153, Magarpatta city Road, Hadapsar Pune-411013
Pune
MAHARASHTRA 		 02066285000

minishjain009@gmail.com 
Dr Varun Bafna  Om Sai Onco Care Hospital  Dr LAD colony, sugarmill corner, Bawada, Kolhapur 416006
Kolhapur
MAHARASHTRA 		 08237780666

omsaioncoiec@gmail.com 
Dr Sweta Lunkad  Oyster and Pearl Hospital  1671-75, Ganeshkhind Rd, near Hotel Pride, Narveer Tanaji Wadi, Shivajinagar, Pune, Maharashtra 411016
Pune
MAHARASHTRA 		 8956457035

kotharisweta6@gmail.com 
Dr Seema Devi  Regional Cancer Centre  IGIMS Sheikhpura, Patna, Bihar- 800014
Patna
BIHAR 		 06122297099

drseemarccigimstrial@gmail.com 
Dr Vaibhav Choudhary  RST Regional Cancer Hospital & Research Centre  Tukdoji Chowk, Manewada Road, Nagpur-440024
Nagpur
MAHARASHTRA 		 07122744441

dr.vaibhav155@gmail.com 
Dr Shashikant Janardan Apte  Sahyadri Super Speciality Hospital  30 C, Erandwane Karve Road, Pune 411004 Maharashtra, India
Pune
MAHARASHTRA 		 02067213000

shashikant.apte@gmail.com 
Dr Vikas Goyal  Sanjeevani Cancer Hospital  Dewada colony, Pachpedi Naka, Raipur-492 001
Raipur
CHHATTISGARH 		 07714061010

drvikasg268@gmail.com 
Dr Anita Ramesh  Saveetha Medical College & Hospital  Saveetha Nagar, Thandalam, Chennai-602105, Tamilnadu-India
Chennai
TAMIL NADU 		 04466726645

anitachandra100@hotmail.com 
Dr Satheesh CT  Shetty’s Hospital  Plot No 11 & 12, 12th ‘F’ Main, Kaverinagar, Bommanahalli, Bangalore-560068, Karnataka-India
Bangalore
KARNATAKA 		 08040943039

drsatheeshct@gmail.com 
Dr R Deivanayagam  Shifa Hospital  82, Near Junction Flyover, Kailasapuram, Middle Street, Tirunelveli Town, Meenakshipuram, Tirunelveli, Tamil Nadu 627001
Tirunelveli
TAMIL NADU 		 9444308036

drdeivan@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospital and Critical Care (P)  A/407 Saheed Nagar, Bhubaneswar
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
Dr Rajeev LK  Sri Venkateswara Hospital  27, 29th Main Road, Rashtra Kuvempa nagar, BTM 2nd Stage, BTM Layout, Bengaluru-560076 Karnataka
Bangalore
KARNATAKA 		 08049730808

lkrajeev@gmail.com 
Dr A Rajeshwar  Srikara Hospital  222, Mythri Nagar, Phase II, Madinaguda Landmark: Near Reliance Fresh Miyapur, Hyderabad
Hyderabad
TELANGANA 		 9949148484

mnjiorcchyd3@gmail.com 
Dr V Arumugam  Tirunelveli Government Medical College & Hospital  North High Growth, Palayamkottai, Tirunelveli- 627 011
Tirunelveli
TAMIL NADU 		 04622572733

arumugamonco@gmail.com 
Dr Dharmesh Vaghasiya  Tristar Hospital-1  Opp. T&TV High School, Nanpura, Surat-395001, Gujrat, India
Surat
GUJARAT 		 7767054520

drvaghasiyad36@gmail.com 
Dr Ankit Patel  Unique Hospital Multispeciality and Research Institute  Opp. Kiran Motors, Nr. Canal, Civil Char Rasta, Sosyo Circle Lane, Off. Ring Road, Surat
Surat
GUJARAT 		 9825404202

drankitoncologist@gmail.com 
Dr Manjunath Nandennavar  Vydehi Institute of Medical Science & Research Centre  #82, EPIP Area, Nallurahalli, Whitefield Bangalore-560066
Bangalore
KARNATAKA 		 08028413381

manjunathndr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 37  
Name of Committee  Approval Status 
Anand Institutional Ethics Committee  Approved 
ETHICAL REVIEW BOARD Meenakshi Mission Hospital & Research Centre  Approved 
Ethics Committee - Sri Venkateshwara Hospitals  Approved 
Ethics Committee Kamalnayan Bajaj Hospital  Approved 
Ethics Committee N S C B C Research Institute  Approved 
Ethics Committee N.R.S. Medical College  Approved 
Ethics Committee Shetty’s Hospital  Approved 
Ethics Committee, Meditrina Institute of Medical Sciences  Approved 
HCG Central Ethics Committee  Approved 
HCG NCHRI Institutional Ethics Committe   Approved 
Health Point Ethics Committee  Approved 
IEC, IMS & SUM Hospital  Approved 
Instituitional Ethics Committee Sparsh Hospital  Approved 
Instituitional Ethics CommitteeHCG Panda Curie Cancer Hospital  Approved 
Institutional Ethics Committee MNJIORCC Ethics Committee  Approved 
Institutional Ethics Committee All India Institute of Medical Sciences Bhubaneswar  Approved 
Institutional Ethics Committee Deep Hospital  Approved 
Institutional Ethics Committee Hindu Mission Hospital  Approved 
Institutional Ethics Committee Indira Gandhi Institute of Medical Sciences (IGIMS)  Approved 
Institutional Ethics Committee of DMIMS  Approved 
Institutional Ethics Committee SGRDIMSAR  Approved 
Institutional Ethics Committee- Vydehi Institute of Medical Science & Research Centre  Approved 
Institutional Ethics Committee-Saveetha Medical College Hospital  Approved 
Ishwar Hospital Ethics Committee  Approved 
Jawaharlal Nehru Cancer Hospital and research centre  Approved 
Kolhapur Cancer Centre Institutional Ethics Committee  Approved 
Lokmanya Medical Research Centre Ethics Committe  Approved 
Manavata Clinical Research Insititute  Approved 
Mumbai Oncocare Centre IEC  Approved 
O AND P ETHICS COMMITTEE  Approved 
Om Sai Onco Institutional Ethics Committee  Approved 
RST Charitable Cancer Hospital and Research Centre - Institutional Ethics Committee  Approved 
Sanjeevani Cancer Hospital IEC  Approved 
Shifa Hospital IEC  Approved 
Shree Institutional Ethics Committee  Approved 
Tristar Hospital Ethics Committee   Approved 
Unique Hospital Multispecialty and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C900||Multiple myeloma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bortezomib Injection 3.5 mg/0.2 ml  Patients will receive a single subcutaneous (SC) dose, 1.3 mg/m2 of Bortezomib, Test Product as per the randomization schedule.  
Comparator Agent  VELCADE (Bortezomib) for Injection 3.5 mg /vial  Patients will receive a single subcutaneous (SC) dose, 1.3 mg/m2 of Bortezomib, Reference Product as per the randomization schedule. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. Patient with histopathologically/ cytologically confirmed multiple myeloma.
ii. Adult multiple myeloma patients weighing between 45 to 80 kg (both inclusive) who are naïve and/or under treatment with Bortezomib or relapsed multiple myeloma (who have previously
responded to treatment with Bortezomib either alone or in combination and who have relapsed at least 6 months after the prior therapy).
iii. Patient with ECOG (Eastern Co-operative Oncology Group) performance status ≤ 2.
iv. Patient with performance ≥70% Karnofsky performance status scale.
v. Patient must have adequate bone marrow (Hemoglobin levels ≥ 8.0 g/dL, ANC ≥1500/mm3 and platelet count ≥ 1,00,000/mm3) prior to enrollment.
vi. Patient must have adequate renal function (Serum creatinine ≤ 1.5 times of ULN). About 10% of Renal impaired patients will be enrolled who have Cockcroft-Gault creatinine clearance ≥ 30 ml/min with an upper limit of 89 ml/min.
vii. Patient must have adequate hepatic function (Serum bilirubin ≤ 1.5 times of ULN and AST/ALT ≤ 2.0 times of ULN).
viii. Subject who have no evidence of underlying disease which in the judgement of the investigator would not make the subject inappropriate for getting enrolled in the study (except multiple myeloma), during screening.
ix. Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial.
x. Patient with life expectancy of at least four months.
xi. In the opinion of the investigator, patient should be able to comply with study procedures.
xii. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal (females who have had a natural menopause for at least 24 consecutive months), must agree to use two effective methods of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 60 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
xiii. In case of male patients: Male patients must agree to practice complete abstinence or agree to use a condom during sexual contact with a female even if they have had a successful vasectomy.
It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. 
 
ExclusionCriteria 
Details  i. Known hypersensitivity to Bortezomib or to any of the excipients, Cyclophosphamide and Dexamethasone.
ii. If the patient had undergone prior surgery, chemotherapy, or other anti- cancer therapy within 4 weeks (28 days), thalidomide and/or lenalidomide within 2 weeks prior to dosing in the study.
iii. Patient with known human immunodeficiency virus (HIV) infection.
iv. A positive hepatitis screen including HBSAg and HCV antibodies.
v. Use of any recreational drugs or history of drug addiction.
vi. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)) or history of
additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval.
vii. History of venous thromboembolism or disease that aggravate risk for thromboembolism.
viii. Patient taking concurrent medications at entry that may act as inhibitors/inducers of CYP3A4 CYP2C19 and CYP1A2.
ix. Patient with cardiac disease known and clinically significant grade 2 neuropathy, pulmonary, hepatic, gastrointestinal, endocrine, immunologic, dermatological, musculo-skeletal, psychiatric, neurological, proven amyloidosis and secondary malignancy.
x. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.
xi. Patient participated in any drug intervention study and donated blood within 90 days prior to the current study.
xii. Female patients with pregnancy or breast-feeding.
xiii. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the Cmax and AUC0-Ï„ between Test and Reference Products on Day 1 and Day 15.  During the entire duration of the trial 
 
Secondary Outcome  
Outcome  TimePoints 
a) To assess the injection site reactions (local tolerability) of the investigational drug product(s).
b) To monitor adverse events and ensure the safety of subjects. 		 During the entire duration of the trial  
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   22/06/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is an An open label, Multi-Centre, Randomized, Two-treatment, Multi dose, Parallel, Comparative Bioavailability Study of Test Product (Bortezomib Injection 3.5 mg/0.2 ml of Shilpa Medicare Ltd, India) and  Reference Product (VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2 Distributed and Marketed by Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or under treatment with Bortezomib or Relapsed Multiple Myeloma patients. 
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