CTRI/2025/08/092681 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On:
08/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
This is a study to Investigate Safety, Efficacy,
Pharmacokinetics and Immunogenicity of Intas Daratumumab (INTP33)
Compared of DARZALEX® in Transplant-Ineligible Participants with Newly
Diagnosed Multiple Myeloma
Scientific Title of Study
A Prospective, Randomized, Double-Blind, Active-Controlled,
Multi-Centre, Two-Arm, Phase-I/III Study to Investigate Safety, Efficacy,
Pharmacokinetics and Immunogenicity of Intas Daratumumab (INTP33)
Compared of DARZALEX® in Transplant-Ineligible Participants with Newly
Diagnosed Multiple Myeloma
"Pushpanjali Hospital and Research Center private limited"
Department of Clinical research, Room No. NA, First floor,Clinical Research Department,
Pushpanjali hospital and researcch center pvt. ltd. near pushpanjali palace.
Agra UTTAR PRADESH
7020617254
dr.mangalrohit@gmail.com
Dr Sourav Mishra
AIIMS, Bhubaneshwar
Department of Clinical research, Room No. NA, All India Institute of Medical Sciences,
OPD Building, Department of medical oncology & haematology, Ground floor,G block, Sijua, Patrapada, Bhubaneswar
751019, Odisha, India
Khordha ORISSA
7008651823
drskmishra.trial@gmail.com
Dr Ashish Gupta
Amerix Cancer Hospital-Society of Unique hospital & Research Institute
Opposite-Welcome Hotel, Sector-19, Dwarka, New Delhi-110075
New Delhi DELHI
9899258492
drashishgupta.onco@gmail.com
Dr T Deenadayalan
Apollo Speciality Hospitals
Department of Clinical research, Room No. NA, Lake view road, K.K. Nagar Madurai-625020. Tamilnadu, India
Madurai TAMIL NADU
9952347659
drdeena06@gmail.com
Dr Pankaj Malhotra
Department of Clinical haematology and medical oncology., Nehru hospital,
Department of Clinical research, Room No. NA, Post Graduate Institute of Medical Education Research Nehru hospital PGIMER Sector 12 Chandigarh-160012 India
Chandigarh CHANDIGARH
7087009680
malhotrapankaj@hotmail.com
Dr Akash Tiwari
DNS Hospital Pvt. Ltd
Department of Clinical research, Room No. NA, 14 Anoop Nagar, LIG Square, A.B. Road,
Indore-452008, MP, India
Indore MADHYA PRADESH
9968721696
akash07tiwari@gmail.com
Dr Varun Bafna
Dr. Bafnas Star Superspeciality Hospital
Department of Clinical research, Room No. NA, Dr. Bafnas Star Superspeciality Clinic and Hospital, Rukmini Nagar, E ward, Near LIC Ground, Kolhapur-416005 Maharashtra, India
Kolhapur MAHARASHTRA
9422415378
starresearch22@gmail.com
Dr M Pandidurai
Government Royapettah Hospital
No. 01, West Cott Road, Royapettah, Chennai-600014, Tamil Nadu
Chennai TAMIL NADU
8248461542
pandi19@gmail.com
Dr Divyesh Patel
HCG Cancer Centre
Department of Clinical research, Room No. NA, Opp. Satsang Party Plot, Sun Pharma
road, Vadodara-390012, Gujarat India
Vadodara GUJARAT
9978906225
drdivyesh.p@hcgel.com
Dr Jitendra Pehaljani
HCG Cancer Centre
Department of Clinical research, Room No. NA,, Shipra Path 52/36, Ward 27, Sector 5,
Mansarovar, Jaipur-302020, Rajasthan,
India
Jaipur RAJASTHAN
9902743251
jitendrakumar.p@hcgel.com
Dr LP Bhaskar Bhuvan
HCG Cancer Centre
Department of Clinical research, Room No. NA, HCG Cancer Center plot no.10, Survey no. 13 P, APIIC Health City, Chinagadili, Arilova, Visakha Patnam-530040. AP India.
Visakhapatnam ANDHRA PRADESH
9154144100
drbhaskarbhuvan.lp@hcgel.com
Dr Ankit Raiyani
HCG Hospitals
Department of Clinical research, Room No. NA, Mithakhali Six Roads, Kalyan Society, Maharashtra Society, Ellisbridge, Ahmedabad, Gujarat - 380006
Ahmadabad GUJARAT
7798438250
adraiyani@gmail.com
Dr Raj Nagarkar
HCG Manavata Cancer Centre
Department of Clinical research, Room No. NA, HCG Manavata Cancer Center, Behind Shivang Auto, Mumbai Naka, Nashik-422002, Maharashtra India.
Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Abhijit Baheti
Indrayani Hospital & Cancer Institute
Department of Clinical research, Room No. NA, Indrayani Hospital and Cancer Institute Alandi chakan Road, Alandi Devachi, Tel. Khed, Pune 412105
Pune MAHARASHTRA
9822426177
abhijitbaheti15@gmail.com
Dr Manoj M Toshniwal
Jeevan Amrut Hematology Centre
Department of Clinical
research, Room No.
NA, Jeevan Amrut Hospital, Plot no. 47, Parijat Nagar, Sector N-4 CIDCO, Near Gokul sweets, Chhatrapati Sambhajinagar(Aurangabad), Maharashtra, India 431001
Aurangabad MAHARASHTRA
9225300842
dr.manojtwal@gmail.com
Dr Riya Ballikar
KIMS Kingsway Hospitals
Department of Clinical research, Room No. NA, KIMS Kingsway Hospitals,
44, Parwana Bhawan,Kingsway, Nagpur -440001
Maharashtra, India
Nagpur MAHARASHTRA
8334988584
riabalikar86@gmail.com
Dr Rohan Bhise
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Department of Clinical research, Room No. NA, Department of Clinical research, Room No. NA, Nehrunagar, Belgavi 590010, Karnataka, India
Belgaum KARNATAKA
9448866712
rohanbhise30@gmail.com
Dr Ankit Jitani
Marengo CIMS Hospital
Department of Clinical research, Room No. NA, Plot No. 67/1, Opp. Panchamrut bunglow, Near Shukan Mall, Off. Science City Road, Sola, Ahmedabad, Gujarat-380060, India
Ahmadabad GUJARAT
8794601030
ankit.jitani@marengoasia.com
Dr P Krishna Chaitanya
MNJ Institute of Oncology & Regional Cancer Centre
Department of Clinical research, Room No. NA, Old Building, 3rd Floor, Clinical Trial Room No 11, Red Hills, Hyderabad- 500004, Telangana, India
Hyderabad TELANGANA
8897199994
mnjiorccchaithanya@gmail.com
Dr Ashray Kole
MOC Cancer care & Research Center (Unit of cellular Cancer Centre Pvt. Ltd)
Department of Clinical research, Room No. NA, 1st floor, Blue nile building Junction of Almeda Road, LBC Road, Next to pinnacle hospital, charai chandwadi signal, Thane-400601, maharashtra, India
Thane MAHARASHTRA
9148282422
dr.ashraykole@mocindia.co.in
Dr Tuphan Kanti Dolai
Nilratan Sirkar Medical College & Hospital
Department of Clinical research, Room No. NA, 138, A.J.C Bose Road, Kolkata-700014, West Bengal, India
Kolkata WEST BENGAL
9874890275
tkdolai75@gmail.com
Dr Rushabh Kothari
Oncowin Cancer Centre
Department of Clinical research, Room No. NA, Oncowin Cancer Centre, 7th floor,HR Elanza, vikas Gruh Road Nr. mahalaxmi five Roads, Paldi, Ahmedabad-380007, Gujarat, India
Ahmadabad GUJARAT
9167196692
rushabhkothari13@yahoo.com
Dr Aditi Thanky
Rajkot Cancer Society
Department of Clinical research, Room No. NA,
Rajkot Cancer Society 1-Tirupati Nagar,Opp. Nirmala Convent school, Rajkot-360007, Gujrat India
Rajkot GUJARAT
9925025381
aditik2008@yahoo.com
Dr Sandeep Jasuja
RK Birla Cancer center, SMS Medical college and attached hospital
Department of Clinical research, Room No. NA, RK Birla Cancer center, SMS Medical college and attached hospital, JLN Marg Jaipur 302004, Rajasthan India.
Jaipur RAJASTHAN
9660121475
sandeepjasuja@gmail.com
Dr Shashikant Apte
Sahyadri Speciality Hospitals
Department of Clinical research, Room No. NA, Survey No. 185A, Shastri Nagar, Near MSEB Office Yerwada, Nagar Road, Pune-411006, Maharashtra, India
Pune MAHARASHTRA
9822404983
shashikant.apte@gmail.com
Dr Nirali Trivedi
Shankush Hospitals Private Limited
Department of Clinical research, Room No. NA, B/h Divine Child school, Near Shankus
water park, Ahmedabad-Mehsana highway, Baliyasan Mehsana-382732, India.
Mahesana GUJARAT
8980008109
dr.nirali@shankushospitals.com
Dr Alpesh Kikani
Shashwat Hemato-Onco Associates LLP
Department of Clinical research, Room No. NA, 2nd Floor, CIGIS Hospital, Near Balaji
Hall, 150 Feet ring road, Rajkot-360004 Gujarat, India.
Rajkot GUJARAT
Department of Clinical research, Room No. NA, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Rama Nagar, Jolly Grant, Dehradun
Dehradun UTTARANCHAL
8923328257
avritibaveja@gmail.com
Dr Karthick R G
Sri Shankara Cancer Hospital & Research Centre (SSCHRC)
Department of Clinical research, Room No. NA, Sri Shankara Cancer Hospital & Research Centre (SSCHRC), 1st cross Shankarapuram, Shankara Math primises, Basavangudi, Bengaluru urban, Karnataka, India 560004
Bangalore KARNATAKA
8105824400
drkarthickrg@sschrc.org
Dr Rakesh Taran
Taran Onco care
Department of Clinical research, Room No. NA, 1, Ravindra Nagar, Near Patrakar Square, Indore-452018
Indore MADHYA PRADESH
9009779517
rakeshtaran@yahoo.com
Dr Sachin Jadhav
Trustwell hospital private limited
Department of Clinical research, Room No. NA, 5, J C Road, Vinobha Nagar, Sudhama Nagar, Bengaluru-560002, Karnataka
Bangalore KARNATAKA
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research, Dr. Pankaj Malhotra
Approved
Institutional Ethics Committee, AlIMS, Dr Sourav Mishra
Approved
Institutional Ethics Committee, Clinical Studies apollo speciality hospitals, Dr. T Deenadayalan
Approved
Institutional Ethics Committee, Government Kilpauk Medical College & Hospital, Dr. Pandi Durai
Approved
Institutional Ethics Committee, KLE University, Dr Rohan Bhise
Approved
KIMS Kingsway Hospitals Ethics Committee, Dr. Riya Ballikar
Approved
Manavata Clinical Research Institute Ethics Committee, Dr. Raj Nagarkar
Submittted/Under Review
MNJ Institute of Oncology and Regional Cancer Centre Ethics Committee, Dr. P Krishna Chaitanya
Approved
Mumbai Oncocare Centre IEC Cellcure, Dr. Ashray Kole
Approved
Narsimha Saraswati Medical Foundation Indrayani Hospital And Cancer Institute, Dr. Abhijit Baheti
Approved
Oriion Citicare Hospital Institutional EC, Dr. Manoj M Toshniwal
Approved
Puspanjali Hospital Ethics Commitee, Dr. Rohit Mangal
Approved
Rajkot Cancer society Ethics Commitee, Dr. Aditi Thanky
Approved
Rectitude Ethics Committee, Dr Akash Tiwari
Approved
Rectitude Ethics Committee, Dr. Rakesh Taran
Approved
Sahyadri Hospitals Pvt. Ltd. Ethics committee, Dr. Shashikant Apte
Approved
Sangini Hospital Ethics Committee, Dr. Rushabh Kothari
Approved
Zenith Institutional Ethics Committee, Dr. Varun Bafna
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C00-D49||Neoplasms,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
DARZALEX Injection, for intravenous use
Dose: Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL). Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL). Route of Administration: IV infusion Duration of Dose: 06 cycles, each cycle is 28 days
Intervention
Intas daratumumab (INTP33) Injection, for intravenous use
Dose: Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL). Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Route of Administration: IV infusion
Duration of Dose: 06 cycles, each cycle is 28 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1) Must sign an ICF indicating that the participant understands the purpose of and procedures required for the study as described in section 10.1.3 and in this protocol and is willing to participate in the study.
2) Male and Female participants must be greater than or equal to 18 years (completed) when signing the informed consent.
3) Participants must have documented diagnosis of multiple myeloma as defined by International Myeloma Working Group updated criteria (Appendix 9).
4) Evidence of measurable disease, as assessed by local laboratory, defined by any of the
following: Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g per dL measured using serum protein immunoelectrophoresis (sPEP) OR urine M-protein level reater than or equal to 200 mg per 24 hours measured using urine protein immunoelectrophoresis (uPEP) AND OR Serum free light chain multiple myeloma without measurable disease in serum or urine as per previous criteria: Serum Ig involved free light chain greater than or equal to 10 mg per dL and abnormal serum Ig kappa to lambda free light chain ratio.
5) Be newly diagnosed and not considered candidate for high-dose chemotherapy with ASCT as
per investigator’s assessment due to any of the following: Ineligible due to advanced age; OR Ineligible due to the presence of important comorbid condition(s) likely to have impact
on tolerability of high dose chemotherapy with ASCT; OR Deferral of high-dose chemotherapy with ASCT as initial treatment for any other reasons
6) Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status
score of 0, 1, or 2 (Refer to Appendix 5)
7) Participants must have screening clinical laboratory values meeting the following criteria:
a) Haemoglobin greater than or equal to 7.5 g per dL (prior transfusion support or ESA is permitted but must be without transfusion support or ESA use within 7 days before the screening laboratory assessment)
b) Absolute neutrophil count (ANC) greater than or equal to 1.0 into 109 per L (prior growth factor support is permitted but must be without support within 7 days for G-CSF or GM-CSF and 14 days for pegylated-GCSF of the screening laboratory assessment)
c) Platelet count greater than or equal to 70,000 per uL if less than 50 percentage of BM nucleated cells are plasma cells, or greater than or equal to 50,000 per uL if greater than or equal to 50 percentage of BM nucleated cells are plasma cells (without transfusion support or thrombopoietin
receptor agonist within 3 days of the screening laboratory assessment)
d) Aspartate aminotransferase (AST) less than or equal to 2.5 into upper limit of normal (ULN)
e) Alanine aminotransferase (ALT) less than or equal to 2.5 into ULN
f) Total bilirubin less than or equal to 2 into ULN, except in participants with congenital bilirubinaemia, such as Gilbert syndrome (in which case direct bilirubin less than or equal to 2.0 into ULN is required).
g) Creatinine clearance greater than 30 mL per min based on Cockcroft-Gault (Refer to Appendix 6 for details).
h) Potassium level greater than or equal to 3.0 mEq per L
i) Corrected serum calcium less than 14 mg per dL (less than 3.5 mmol per L); or free ionized calcium less than 6.5 mg per dL (less than 1.6
mmol per L) (Appendix 7)
8) A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly
effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 03 months after the last dose of the study intervention. The investigator
should evaluate the effectiveness and the potential for contraceptive method failure (e.g.,
noncompliance, recently initiated) of the contraceptive method in relation to the first dose
of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of
contraception. A WOCBP must have a negative highly sensitive pregnancy test serum as required by
local regulations within at screening and urine pregnancy test on day 1 randomization,
before the first dose of the study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum
pregnancy test is required. In such cases, the participant must be excluded from
participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are
located in section 8.3.8. The investigator is responsible for reviewing medical history, menstrual history, and recent
sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
Contraceptive use by participants or participant’s partners should be consistent with local
regulations regarding the methods of contraception for those participating in clinical studies.
9) Male participants are eligible to participate if they agree to the following during the
intervention period and for at least 04 months after the last dose of study intervention: Must agree not to plan to father a child or donate sperm for reproduction. PLUS, either of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR Must agree to use contraception barrier as detailed below a male participant must wear a condom when engaging in any activity that allows for the passage of ejaculate to another person with female partner use of an additional highly effective contraceptive method with a failure rate of less than 1 percentage per year as described in Appendix 4
10) Willing and able to adhere to the lifestyle restrictions specified in this protocol.
ExclusionCriteria
Details
1) Known allergies, hypersensitivity, or intolerance to any of the study interventions
(daratumumab, lenalidomide and dexamethasone) or components excipients thereof (refer to
the IB of daratumumab and local prescribing information documents of DARZALEX,
lenalidomide and dexamethasone), or drug or other allergies to monoclonal antibodies or
human proteins, or known sensitivity to mammalian-derived products, that in the opinion of the investigator or medical monitor, contraindicate participation in the study.
2) Contraindications to the use of lenalidomide and dexamethasone per local prescribing
information.
3) Diagnosis of plasma cell leukaemia at the time of screening; systemic light chain amyloidosis; POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes); or Waldenström’s disease or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
4) Any treated plasma cell dyscrasia [e.g., multiple myeloma, smoldering multiple myeloma
(SMM), monoclonal gammopathy of undefined significance (MGUS)] with following
exceptions: a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or
equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In
addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equal to 20 mg of dexamethasone during the Screening Phase.
5) Prior or current systemic therapy or stem cell transplant (SCT) for MM, with the exception of
an emergency use of a short course (equivalent of dexamethasone 40 mg per day for a maximum
4 days) of corticosteroids before treatment.
6) Participants will be excluded if they have any of the following: Any history of malignancy in the last 3 years prior to randomization, other than multiple myeloma, SMM and MGUS which is considered at high risk of recurrence requiring
systemic therapy OR Any active malignancy (i.e., progressing or requiring treatment change) in the last 3 years prior to randomization other multiple myeloma, SMM and MGUS. The only allowed exceptions are malignancies treated within the last 3years that are considered cured: Non-muscle invasive bladder cancer Nonmelanoma skin cancer or lentigo maligna who underwent adequate treatment with
no active disease at present Non-invasive cervical cancer Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ,
or history of localized breast cancer and receiving antihormonal agents and considered
to have a very low risk of recurrence Adequately treated carcinoma in situ Localized non-invasive primary disease under surveillance Localized prostate cancer (Any T, N0M0): Very-low, low or intermediate risk group, treated (radical prostatectomy/radiation
therapy focal treatment; with or without ADT) or untreated and under either
observation or active surveillance; OR High or very-high risk group who have completed the treatment with curative intent
(including adjuvant ADT) more than 6 months prior to full study screening and
considered to have a very low risk of recurrence; Other malignancy that is considered cured with minimal risk of recurrence with low
potential risk for risk of metastasis or death (e.g., 5-year OS rate greater than 90 percentage) in consultation with the sponsor’s medical monitor
7) Received focal radiation therapy within 14 days of randomization. However, if the radiation is
given for palliative purposes and the radiation portal covered less than or equal to 5 percentage of the bone marrow reserve5, the participant is eligible irrespective of the end date of radiotherapy. Radiotherapy within 14
days on measurable soft-tissue plasmacytoma(s) is not permitted even in the setting of
palliation for symptomatic management.
8) Any major procedure within 14 days before the initiation of the study treatment:
plasmapheresis, major surgery (kyphoplasty is not considered a major procedure).
9) Clinical signs of CNS or meningeal involvement of multiple myeloma. If either is suspected,
negative brain and total spine MRI (with and without contrast) and cerebral spinal fluid
cytology are required.
10) Has moderate or severe persistent asthma within the past 2 years OR uncontrolled asthma of
any classification (Participants who have controlled intermittent asthma or control mild
persistent asthma are allowed in the study).
11) Has COPD with an FEV1 less than 50 percentage of predicted (FEV1 testing is required only for participants suspected of having COPD).
12) Presence of hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) total
immunoglobulin (Ig) or IgG at screening or within 3 months prior to the first dose of
investigational intervention.
13) Positive hepatitis C antibody test result at screening or within 3 months prior to starting the
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior
resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is
obtained.
14) Has known human immunodeficiency virus (HIV) seropositive status or positive HIV antibody
test at screening. For participants with unknown HIV status, HIV testing will be performed at
screening unless prohibited by local regulations.
15) Presence of medical or psychiatric diseases (e.g., active systemic infection, uncontrolled
diabetes, acute diffuse infiltrative pulmonary disease) that is a safety risk or interfere with
assessment as per investigator assessment.
16) Participant with clinically significant current or recent (within the past 6 months before
randomization [unless otherwise specified below]) cardiac conditions as defined below:
a) Acute coronary syndrome, stroke (including transient ischemic attack [TIA]) or other ischemic
event or thromboembolic event (e.g., deep vein thrombosis [DVT], pulmonary embolism)
b) Clinical risk assessment of cardiac function using the New York Heart Association Functional
Classification of Class III or greater
c) Clinically significant cardiac arrhythmia (serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality) as per investigator assessment
d) Electrocardiographic evidence of clinically significant acute ischemic or active conduction
system abnormalities which is medically relevant and affect safety as per investigator
assessment.
e) Any other cardiac illness that could lead to a safety risk to the participant
f) Participants with a known left ventricular ejection fraction (LVEF) less than 40 percentage at the screening assessment. Note: Participants with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF less than 50 percentage must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist, if appropriate.
17) Participants are not expected to comply with the requirement of the protocol as per the
investigator assessment (alcoholics, drug addicts, psychiatric patients, or medical condition).
Participant as per investigator is not medically fit or have a situation which can affect safety or
efficacy assessment.
18) Had major surgery within 2 weeks before randomization or has not fully recovered from
surgery as per investigators assessment.
19) Contraindications to prophylaxis for deep vein thrombosis and pulmonary embolism.
20) Past or intended use of any disallowed therapies as noted in section 6.9, Prior and Concomitant
Therapy within 30 days prior to the first dose of the study intervention.
21) Presence of gastrointestinal disease that can affect absorption of drugs.
22) Woman who is pregnant, or breastfeeding, or planning pregnancy during study. OR, Man
wanting to father a child during study.
23) Received any other investigational intervention or used an invasive investigational medical device within 04 weeks or 5 half-lives prior to the first dose of study intervention, whichever is longer. 24 Documented medical history of uncontrolled, clinically significant intercurrent medical
condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or
confound the protocol-specified assessments.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To establish the non-inferiority of Intas
daratumumab (INTP33), lenalidomide and
dexamethasone against DARZALEX, lenalidomide and dexamethasone in terms of overall response rate (ORR) in transplant-ineligible participants with newly diagnosed
multiple myeloma
0.000 (Pre-dose), 0.500, 1.000 and 3.000 hours after start of infusion, End of infusion, 0.500, 1.000, 2.000, 3.000, 5.000 hours after completion of infusion, 24.000, 48.000 hours after start of infusion, 120.000, 144.000 hours after start of infusion, 168.000 hours after start of infusion
Secondary Outcome
Outcome
TimePoints
To establish the anti-tumour activity of Intas
daratumumab (INTP33), lenalidomide and
dexamethasone against DARZALEX,
lenalidomide and dexamethasone in
transplant-ineligible participants with newly
diagnosed multiple myeloma
To establish the anti-tumour activity of Intas
daratumumab (INTP33), lenalidomide and
dexamethasone against DARZALEX,
lenalidomide and dexamethasone in
transplant-ineligible participants with newly
diagnosed multiple myeloma
To compare pharmacokinetic parameters
after 1st dose of Intas daratumumab with
DARZALEX, both given in combination
with lenalidomide and dexamethasone in
transplant-ineligible participants with newly
diagnosed multiple myeloma
To compare trough blood levels during the
treatment cycles in transplant-ineligible
participants with newly diagnosed multiple
myeloma
0.000 (Pre-dose), 0.500, 1.000 and 3.000 hours after start of infusion, End of infusion, 0.500, 1.000, 2.000, 3.000, 5.000 hours after completion of infusion, 24.000, 48.000 hours after start of infusion, 120.000, 144.000 hours after start of infusion, 168.000 hours after start of infusion
Target Sample Size
Total Sample Size="238" Sample Size from India="238" 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)
18/08/2025
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="0" Months="7" 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
To establish the non-inferiority of Intas daratumumab (INTP33), lenalidomide and dexamethasone against DARZALEX, lenalidomide and dexamethasone in terms of overall response rate (ORR) in transplant