Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
45
Countries
1
Sites
2
Multiple Myeloma
To provide elotuzumab and/or other study drugs to subjects who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.
Key facts
- Sponsor
- Bristol Myers Squibb International Corporation
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Apr 2021 → 24 Feb 2026
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb International Corporation
External identifiers
- EU CT number
- 2024-515490-10-00
- EudraCT number
- 2016-000037-51
- WHO UTN
- U1111-1178-0758
- ClinicalTrials.gov
- NCT02719613
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To provide elotuzumab and/or other study drugs to subjects who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.
Secondary objectives 1
- To monitor the safety and tolerability of elotuzumab
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- - Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol.
- - Receiving elotuzumab and/or other study drugs at the time of signature of informed consent.
- - Males and Females, ages 18 or local age of majority and older, inclusive.
Exclusion criteria 4
- - All subjects previously discontinued from an elotuzumab study for any reason.
- - Subjects not receiving clinical benefit from previous study therapy.
- - Subjects who are not medically well enough to receive study therapy as determined by the investigator.
- Other protocol defined inclusion/exclusion criteria could apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The number of subjects who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.
Secondary endpoints 1
- In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation will be collected. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Empliciti 400 mg powder for concentrate for solution for infusion.
PRD4073310 · Product
- Active substance
- Elotuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 520 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC23 — -
- Marketing authorisation
- EU/1/16/1088/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol Myers Squibb International Corporation
- Sponsor organisation
- Bristol Myers Squibb International Corporation
- Address
- Terhulpsesteenweg 185
- City
- Watermaal-Bosvoorde
- Postcode
- 1170
- Country
- Belgium
Scientific contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT Representative
Public contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT Representative
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Other, Code 2, Data management, E-data capture |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other, Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Data management, E-data capture |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 3 | 2 |
| Rest of world
United Kingdom, Australia, Turkey, Japan, United States, Canada
|
— | 42 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Romania | 2021-04-12 | 2026-02-23 | 2021-04-16 | 2021-05-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Administrative Letter 2024-515490-10-00 Redacted | 10 |
| Protocol (for publication) | D1_Protocol Amendment 2024-515490-10-00 Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Transition Placeholder | NA |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Main Romanian Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis RO_2024-515490-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2024-515490-10-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | Romania | Acceptable 2024-08-13
|
2024-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Romania | Acceptable 2025-01-30
|
2025-02-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-07 | Romania | Acceptable 2025-04-22
|
2025-04-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-15 | Romania | Acceptable 2025-04-22
|
2025-12-15 |