Phase 1b/2a Study to Evaluate Alnuctamab in Combination with Mezigdomide in Relapsed and/or Refractory Multiple Myeloma.

2023-504367-16-00 Protocol CA058-002 Therapeutic exploratory (Phase II) Not authorised

Status Not authorised · 1 EU/EEA countries · 2 sites · Protocol CA058-002

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Not authorised
Participants planned 67
Countries 1
Sites 2

Relapsed and/or Refractory Multiple Myeloma

To determine the safety and tolerability of alnuctamab in combination with mezigdomide in participants with RRMM (primary - all phases). To determine the recommended Phase 2 dose (RP2D) and schedule of mezigdomide when administered in combination with alnuctamab in participants with RRMM (Phase 1b only). To evaluate th…

Key facts

Sponsor
Celgene International II S.a.r.l.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2024-01-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Celgene Corporation

External identifiers

EU CT number
2023-504367-16-00
WHO UTN
U1111-1283-8970

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Therapy, Efficacy, Safety, Pharmacokinetic

To determine the safety and tolerability of alnuctamab in combination with mezigdomide in participants with RRMM (primary - all phases).
To determine the recommended Phase 2 dose (RP2D) and schedule of mezigdomide when administered in combination with alnuctamab in participants with RRMM (Phase 1b only).
To evaluate the preliminary efficacy of alnuctamab in combination with mezigdomide in comparison to alnuctamab monotherapy in participants with RRMM (Phase 2a only).

Secondary objectives 1

  1. To evaluate additional measures of efficacy.

Conditions and MedDRA coding

Relapsed and/or Refractory Multiple Myeloma

VersionLevelCodeTermSystem organ class
21.0 LLT 10028228 Multiple myeloma 10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Age ≥ 18 with history of RRMM treated with ≥ 3 prior lines of antimyeloma therapy (Part A) or 1 to 3 prior lines of anti-myeloma therapy (Parts B and C).
  2. Measurable MM by central laboratory.
  3. Eastern Cooperative Oncology Group performance status of 0 to 1.
  4. Adherence to contraception requirements.

Exclusion criteria 2

  1. Prior treatment with mezigdomide or alnuctamab.
  2. Other exclusion criteria can be found in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

  1. All phases: Type, frequency, seriousness, and severity of all aAEs;. To be assessed continuously for all participants until 80 days after the last dose of alnuctamab or 28 days after the last dose of mezigdomide, whichever is later.
  2. Phase 1b: Establish RP2D and dosing schedule of mezigdomide in combination with alnuctamab for Phase 2a expansion. To be assessed at end of Phase 1.
  3. Phase 2a: Overall response rate. To be assessed every cycle for all participants starting at Cycle 2 Day 1 until end of treatment. Participants in efficacy follow-up may be assessed every 8 weeks until dprogression, withdrawal of consent, death, or initiation of new systemic anticancer therapies.

Secondary endpoints 2

  1. All phases: Other myeloma response measures such as very good partial or better rate and complete response rate; time-to-response (the time it takes for a myeloma response after treatment) and duration of response. These will be assessed for all participants starting at Cycle 2 Day 1. Other measures include progression-free survival (the amount of time after starting treatment that the cancer does not worsen) and overall survival, both of which will be assessed continuously
  2. Phase 1b: overall response rate. To be assessed every cycle for all participants starting at Cycle 2 Day 1 until end of treatment. Participants in efficacy follow-up may be assessed every 8 weeks until dprogression, withdrawal of consent, death, or initiation of new systemic anticancer therapies.

Investigational products

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

Test 7

Alnuctamab

PRD10742224 · Product

Active substance
Alnuctamab
Substance synonyms
EM-901, CC-93269, BMS-986349
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
9999 mg milligram(s)
Max total dose
9999 mg milligram(s)
Max treatment duration
9999 Day(s)
Authorisation status
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

Alnuctamab

PRD10742225 · Product

Active substance
Alnuctamab
Substance synonyms
EM-901, CC-93269, BMS-986349
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
9999 mg milligram(s)
Max total dose
9999 mg milligram(s)
Max treatment duration
9999 Day(s)
Authorisation status
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

CC-92480 0.4 mg

PRD9852270 · Product

Active substance
Mezigdomide
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
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

CC-92480 0.6 mg

PRD9757642 · Product

Active substance
Mezigdomide
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
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

CC-92480 0.3 mg

PRD9852263 · Product

Active substance
Mezigdomide
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
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

CC-92480 0.2 mg

PRD9757438 · Product

Active substance
Mezigdomide
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
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

Dexamethasone

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
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene International II S.a.r.l.

6 Total trials 5 Ended
Commercial
Sponsor organisation
Celgene International II S.a.r.l.
Address
Route De Perreux 1
City
Boudry
Postcode
2017
Country
Switzerland

Scientific contact point

Organisation
Celgene International II S.a.r.l.
Contact name
GSM-CT

Public contact point

Organisation
Celgene International II S.a.r.l.
Contact name
GSM-CT

Third parties 7

OrganisationCity, countryDuties
Yprime LLC
ORG-100042888
 Malvern, United States Other
Pharmaceutical Product Development LLC
ORG-100016999
 Richmond, United States Other
Accenture Solutions Private Limited
ORG-100032592
 Chennai, India Other
Neogenomics Laboratories Inc.
ORG-100041804
 Aliso Viejo, United States Other
Accenture Solutions Private Limited
ORG-100032592
 Bangaluru, India Other, Code 5
Accenture Solutions Private Limited
ORG-100032592
 Chennai, India Data management
QPS LLC
ORG-100012847
 Newark, United States Other

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Not authorised 14 2
Rest of world
United States, Israel
 — 53 —

Investigational sites

Denmark

2 sites · Not authorised
Aarhus Universitetshospital
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Hematology, J B Winsloews Vej 4, 5000, Odense C

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-09-05 Denmark Not acceptable
2024-01-10
 2024-01-11

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