International treatment-extension study in adult participants with multiple myeloma and who have derived clinical benefit from isatuximab

Start 5 Apr 2023 · Status Ongoing, recruitment ended · 7 EU/EEA countries · 16 sites · Protocol LTS17704

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruitment ended

Participants planned 66

Countries 7

Sites 16

Cancer

To assess the long-term safety of isatuximab administered as monotherapy or in combination regimens in participants previously treated with isatuximab

Key facts

Sponsor: Sanofi-Aventis Recherche & Developpement
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 5 Apr 2023 → ongoing
Decision date (initial): 2024-04-16
Transition trial: Yes
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes

External identifiers

EU CT number: 2023-507180-19-00
EudraCT number: 2022-002253-26
WHO UTN: U1111-1277-6635

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To assess the long-term safety of isatuximab administered as monotherapy or in combination regimens in participants previously treated with isatuximab

Conditions and MedDRA coding

Cancer

Version	Level	Code	Term	System organ class
21.1	PT	10035226	Plasma cell myeloma	100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

- Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.
- Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed.
- Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included.
- Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
- Capable of giving signed informed consent.

Exclusion criteria 7

- Participant has evidence of progressive disease during or at the time of the parental study closure.
- Participant has not recovered to ≤Grade 2 from non-hematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study.
- As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study.
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
- Any country-related specific regulation that would prevent the participant from entering the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Number of participants with treatment-emergent adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 40

Isatuximab

PRD10653408 · Product

Active substance: Isatuximab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 1400 mg milligram(s)
Max total dose: 1400 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Not Authorised
MA holder: SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
Paediatric formulation: No
Orphan designation: No

Zelvina 10 mg hard capsules

PRD8721704 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: MA1339/00504
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Zelvina 20 mg hard capsules

PRD8721743 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: MA1339/00506
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Zelvina 25 mg hard capsules

PRD8721744 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: MA1339/00507
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Zelvina 5 mg hard capsules

PRD8721745 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: MA1339/00502
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Zelvina 15 mg hard capsules

PRD8721724 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: MA1339/00505
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Pomalidomide Adalvo 1 mg hard capsules

PRD11984093 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: MA1339/02201
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Pomalidomide Adalvo 2 mg hard capsules

PRD11984094 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: MA1339/02202
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Pomalidomide Adalvo 3 mg hard capsules

PRD11984095 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: MA1339/02203
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Pomalidomide Adalvo 4 mg hard capsules

PRD11984096 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: MA1339/02204
MA holder: ADALVO LIMITED
MA country: Malta
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132766 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 20 mg/kg milligram(s)/kilogram
Max total dose: 20 mg/kg milligram(s)/kilogram
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/002
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132767 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 20 mg/kg milligram(s)/kilogram
Max total dose: 20 mg/kg milligram(s)/kilogram
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/003
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

SARCLISA 20mg/mL concentrate for solution for infusion.

PRD8132765 · Product

Active substance: Isatuximab
Substance synonyms: Humanised monoclonal antibody against CD38, SAR650984
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 20 mg/kg milligram(s)/kilogram
Max total dose: 20 mg/kg milligram(s)/kilogram
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L01FC02 — -
Marketing authorisation: EU/1/20/1435/001
MA holder: SANOFI WINTHROP INDUSTRIE
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Dexamethason 8 mg JENAPHARM®

PRD988427 · Product

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: H02AB02 — DEXAMETHASONE
Marketing authorisation: 40153.02.00
MA holder: MIBE GMBH ARZNEIMITTEL
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Dexamethason 4 mg JENAPHARM®

PRD988426 · Product

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: H02AB02 — DEXAMETHASONE
Marketing authorisation: 40153.00.00
MA holder: MIBE GMBH ARZNEIMITTEL
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

LIBTAYO 350 mg concentrate for solution for infusion.

PRD7514333 · Product

Active substance: Cemiplimab
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 250 mg milligram(s)
Max total dose: 250 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L01XC33 — -
Marketing authorisation: EU/1/19/1376/001
MA holder: REGENERON IRELAND D.A.C.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: “Difference in pack, label and QP release sites. Material for clinical use may be assigned a longer shelf life compared to the MA”

DexaGalen® 8 mg injekt Injektionslösung

PRD801335 · Product

Active substance: Dexamethasone Sodium Phosphate Ph. Eur.
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: IV INFUSION
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: H02AB02 — DEXAMETHASONE
Marketing authorisation: 49345.01.00
MA holder: GALENPHARMA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Kyprolis 60 mg powder for solution for infusion

PRD3374183 · Product

Active substance: Carfilzomib
Substance synonyms: PR-171
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 56 mg/m2 milligram(s)/square meter
Max total dose: 56 mg/m2 milligram(s)/square meter
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L01XG02 — -
Marketing authorisation: EU/1/15/1060/001
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/08/548
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 5 mg hard capsules

PRD9264287 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/008
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 5 mg hard capsules

PRD9264284 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 10 mg hard capsules

PRD9264292 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/010
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 25 mg hard capsules

PRD9264271 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/004
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 20 mg hard capsules

PRD9264267 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/009
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 25 mg hard capsules

PRD9264311 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/014
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 15 mg hard capsules

PRD9264282 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/003
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 10 mg hard capsules

PRD9264283 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 20 mg hard capsules

PRD9264307 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/013
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Revlimid 15 mg hard capsules

PRD9264288 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/07/391/011
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 2 mg hard capsules

PRD9260805 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/002
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 3 mg hard capsules

PRD9260806 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/003
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 1 mg hard capsules

PRD9260804 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/001
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 1 mg hard capsules

PRD9260809 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Week(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/005
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 4 mg hard capsules

PRD9260814 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/008
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 4 mg hard capsules

PRD9260808 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/004
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 3 mg hard capsules

PRD9260813 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/007
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

Imnovid 2 mg hard capsules

PRD9260810 · Product

Active substance: Pomalidomide
Substance synonyms: CC-4047
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Authorised
ATC code: L04AX06 — -
Marketing authorisation: EU/1/13/850/006
MA holder: BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabeling for clinical supplies

JAMP Pomalidomide

PRD10978182 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Not Authorised
MA holder: SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672

JAMP Pomalidomide

PRD10978187 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Not Authorised
MA holder: SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672

JAMP Pomalidomide

PRD10978287 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Not Authorised
MA holder: SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672

JAMP Pomalidomide

PRD10978237 · Product

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 43 Month(s)
Authorisation status: Not Authorised
MA holder: SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU309672

Auxiliary 5

Montelukast Sodium

SCP1139557 · ATC

Active substance: Montelukast Sodium
Route of administration: ORAL
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: R03DC03 — MONTELUKAST
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone Base

SUB125563 · Substance

Active substance: Dexamethasone Base
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS INJECTION
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lidocaine Hydrochloride Monohydrate

SCP1095637 · ATC

Active substance: Lidocaine Hydrochloride Monohydrate
Route of administration: INTRAVENOUS
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: H02AB04 — METHYLPREDNISOLONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP1159503 · ATC

Route of administration: INTRAVENOUS
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: R06AA02 — DIPHENHYDRAMINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Buclizine Hydrochloride

SCP1081917 · ATC

Active substance: Buclizine Hydrochloride
Substance synonyms: Buclizine dihydrochloride
Route of administration: ORAL
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N02BE01 — PARACETAMOL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation: Sanofi-Aventis Recherche & Developpement
Address: 82 Avenue Raspail
City: Gentilly
Postcode: 94250
Country: France

Scientific contact point

Organisation: Sanofi-Aventis Research & Development
Contact name: Clinical Sciences and Operations

Public contact point

Organisation: Sanofi-Aventis Research & Development
Contact name: Clinical Sciences and Operations

Third parties 6

Organisation	City, country	Duties
Depo-pack S.r.l. ORG-100013780	Saronno, Italy	Other
Suvoda LLC ORG-100043523	Conshohocken, United States	Interactive response technologies (IRT)
Taxi Travel Ticket S.L. ORG-100042292	Barcelona, Spain	Other
Alcura Health Espana S.A. ORG-100020590	Viladecans, Spain	Code 14
ESMS Global Limited ORG-100023149	London, United Kingdom	Other
Sermes CRO ORG-100030576	Madrid, Spain	Other

Locations

7 EU/EEA countries · 16 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ongoing, recruitment ended	1	3
Finland	Ended	1	1
France	Ongoing, recruitment ended	6	1
Greece	Ongoing, recruitment ended	1	3
Italy	Ongoing, recruitment ended	3	1
Spain	Ongoing, recruitment ended	24	6
Sweden	Ongoing, recruitment ended	1	1
Rest of world Chile, Australia, Russian Federation, United States, New Zealand, Taiwan, Korea, Republic of, Brazil, Japan, China	—	29	—

Investigational sites

Czechia

3 sites · Ongoing, recruitment ended

Vseobecna Fakultni Nemocnice V Praze

I. interni klinika, U Nemocnice 499/2, Nove Mesto, Prague

Fakultni Nemocnice Brno

Interní Hematologická a Onkologická Klinika, Jihlavska 340/20, Bohunice, Brno

Fakultni Nemocnice Ostrava

Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava

Finland

1 site · Ended

HUS-Yhtymae

Comprehensive Cancer Center, Haartmaninkatu 4, 00290, Helsinki

France

1 site · Ongoing, recruitment ended

Centre Hospitalier Universitaire De Nantes

Service d'Hematologie, 1 Place Alexis Ricordeau, 44000, Nantes

Greece

3 sites · Ongoing, recruitment ended

Evangelismos S.A.

Department of Hematology and Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens

Alexandra Hospital

Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens

General University Hospital Of Patras

Bone Marrow Transplantation Unit, Rio, 265 04, Patras

Italy

1 site · Ongoing, recruitment ended

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino

Department of Molecular Biotechnology and Health Sciences, Corso Bramante 88, 10126, Turin

Spain

6 sites · Ongoing, recruitment ended

Hospital Universitario 12 De Octubre

Servicio de Hematologia, Bloque D, Avenida De Cordoba Sn, Madrid

Institut Catala D'oncologia

Clinical Hematology department, Carretera Canyet S/n, 08916, Badalona

Clinica Universidad De Navarra

Servicio de Hematologia, Calle Marquesado De Santa Marta 1, 28027, Madrid

Hospital Universitario Marques De Valdecilla

Servicio de Hematologia, Avenida Valdecilla Sn, 39008, Santander

University Hospital Virgen Del Rocio S.L.

Hematology department, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Universitario De Salamanca

Servicio de Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca

Sweden

1 site · Ongoing, recruitment ended

Region Norrbotten

Sunderby sjukhus, Robertsviksgatan 7, Lulea Domkyrkofors., Lulea

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end
Czechia	2023-04-05		2023-04-05	2025-01-03
Finland	2023-04-12	2024-10-23	2023-04-12	2024-10-22
France	2023-06-15		2023-06-15	2025-01-03
Greece	2023-06-29		2023-06-29	2025-01-03
Italy	2024-01-18		2024-01-18	2025-01-03
Spain	2023-07-03		2023-07-03	2025-01-03
Sweden	2023-05-03		2023-05-03	2025-01-03

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 53 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	d1-rdct-protocol-el-2023-507180-19-00	3
Protocol (for publication)	d1-rdct-protocol-en-2023-507180-19-00	3
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en	1.0
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en	1.0
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en	1.0
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-en-waiver	1
Recruitment arrangements (for publication)	K1-recruitment-arrangements-fi	1.0
Recruitment arrangements (for publication)	K1-recruitment-arrangements-fr	1.0
Recruitment arrangements (for publication)	SM_Placeholder Transparency document	1.0
Subject information and informed consent form (for publication)	L1-sis-icf-addendum-fr	1
Subject information and informed consent form (for publication)	L1-sis-icf-addendum-patient-fr	3
Subject information and informed consent form (for publication)	L1-sis-icf-gdpr-cz	2
Subject information and informed consent form (for publication)	L1-sis-icf-main-el	5.1
Subject information and informed consent form (for publication)	L1-sis-icf-parental-efc15246-cs	2
Subject information and informed consent form (for publication)	L1-sis-icf-parental-tcd14906-cs	3
Subject information and informed consent form (for publication)	L1-sis-icf-partner-pregnancy-adolescent-el	1
Subject information and informed consent form (for publication)	L1-sis-icf-partner-pregnancy-aou-torino-it	1.1
Subject information and informed consent form (for publication)	L1-sis-icf-partner-pregnancy-el	1.2
Subject information and informed consent form (for publication)	L1-sis-icf-partner-pregnancy-parents-el	1
Subject information and informed consent form (for publication)	L1-sis-icf-partner-pregnancy-turn-adult-el	1
Subject information and informed consent form (for publication)	L1-sis-icf-partner-pregnany-sv	1
Subject information and informed consent form (for publication)	L1-sis-icf-patient-aou-torino-it	5
Subject information and informed consent form (for publication)	L1-sis-icf-patient-es	5
Subject information and informed consent form (for publication)	L1-sis-icf-patient-fi	7
Subject information and informed consent form (for publication)	L1-sis-icf-patient-fr	2
Subject information and informed consent form (for publication)	L1-sis-icf-patient-information-sheet-aou-torino-it	5
Subject information and informed consent form (for publication)	L1-sis-icf-patient-sv	7
Subject information and informed consent form (for publication)	L1-sis-icf-pregnancy-cs	1
Subject information and informed consent form (for publication)	L1-sis-icf-pregnancy-es	1.2
Subject information and informed consent form (for publication)	L1-sis-icf-privacy-it	1.2
Subject information and informed consent form (for publication)	L2-other-subject-information-material-gp-letter-it	2.1
Summary of Product Characteristics (SmPC) (for publication)	G1-smpc-dexamethasone iv	1
Summary of Product Characteristics (SmPC) (for publication)	G1-smpc-Kyprolis	1
Summary of Product Characteristics (SmPC) (for publication)	g2-smpc-combination-dexamethasone-uk-smpc-advanz	1
Summary of Product Characteristics (SmPC) (for publication)	g2-smpc-combination-UK SmPC-Revlimid	1
Summary of Product Characteristics (SmPC) (for publication)	g2-smpc-combination-UK SmPC-Revlimid	1
Summary of Product Characteristics (SmPC) (for publication)	g2-smpc-combination-uk-smpc-Imnovid	1
Summary of Product Characteristics (SmPC) (for publication)	g2-smpc-combination-uk-smpc-Imnovid	1
Summary of Product Characteristics (SmPC) (for publication)	g2-smpc-combination-uk-smpc-Imnovid	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-cs-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-el-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-en-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-es-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-fi-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-fr-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-it-2023-507180-19-00	1
Synopsis of the protocol (for publication)	d1-lay-protocol-synopsis-sv-2023-507180-19-00	1

Application history

8 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-12-20	France	Acceptable 2024-04-15	2024-04-15
2	SUBSTANTIAL MODIFICATION	SM-1	2024-05-14	France	Acceptable 2024-08-26	2024-08-26
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-09-12	France	Acceptable 2024-08-26	2024-09-12
4	SUBSTANTIAL MODIFICATION	SM-2	2024-10-31	France	No conclusion 2025-02-24	2025-04-17
5	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-08-06	France	No conclusion 2025-02-24	2025-08-06
6	SUBSTANTIAL MODIFICATION	SM-3	2025-08-14	France	Acceptable 2025-11-24	2025-11-25
7	SUBSTANTIAL MODIFICATION	SM-4	2026-01-16		Acceptable	2026-02-24
8	NON SUBSTANTIAL MODIFICATION	NSM-3	2026-05-15	France	Acceptable	2026-05-15

International treatment-extension study in adult participants with multiple myeloma and who have derived clinical benefit from isatuximab

Overview

Key facts

External identifiers

Trial design

Main objective

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 5

Exclusion criteria 7

Endpoints

Primary endpoints 1

Investigational products

Test 40

Auxiliary 5

Sponsors and contacts

Sanofi-Aventis Recherche & Developpement

Scientific contact point

Public contact point

Third parties 6

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 53 files

Application history

Related clinical trials