Trial Title:
A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT ID:
NCT05704049
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Acetaminophen
Diphenhydramine
Promethazine
Dexamethasone
Dexamethasone acetate
Methylprednisolone
Montelukast
BB 1101
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Isatuximab
Description:
Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous
administration; Route of administration: Subcutaneous
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion;
Route of administration: Intravenous
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Other name:
Kyprolis
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical
form: Tablet; Route of administration: Oral
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Intervention type:
Drug
Intervention name:
Dexamethasone IV
Description:
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical
form: Powder for solution for infusion; Route of administration: Intravenous
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Intervention type:
Drug
Intervention name:
Montelukast
Description:
Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial
product; Route of administration: Oral
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Intervention type:
Drug
Intervention name:
Acetaminophen
Description:
Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial
product; Route of administration: Oral or intravenous (IV)
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Intervention type:
Drug
Intervention name:
Diphenhydramine
Description:
Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial
product; Route of administration: Oral or IV
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Intervention type:
Drug
Intervention name:
Methylprednisolone
Description:
Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per
local commercial product; Route of administration: IV
Arm group label:
Cohort 1: manual administration
Arm group label:
Part 1 Cohort 2: manual administration
Arm group label:
Part 2 Randomized Cohort: Manual to OBDS
Arm group label:
Part 2 Randomized Cohort: OBDS to manual
Summary:
The main purpose of this study is to measure the efficacy (Myeloma response) of
subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone
in adult participants with RRMM having received 1 to 3 prior lines of therapy. After
confirmation of the feasibility of SC isatuximab by manual administration, patient will
be randomized to 1 of the 2 delivery methods of SC isatuximab.
Detailed description:
The duration of the study for a participant will include a period for screening of up to
28 days. A cycle duration is 28 days. Participants will be allowed to continue therapy
until disease progression, unacceptable adverse events (AEs), participant request to
discontinue treatment, or any other reason, as well as the study treatment is
commercially available and reimbursed in the participant's country, or is available from
another source, whichever is first. The overall study duration will be of approximately
45 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants must have a documented diagnosis of multiple myeloma (MM)
- Participants with measurable disease defined as at least one of the following:
- Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis
and/or
- Urine M-protein ≥200 mg/24 hours measured using urine protein
immunoelectrophoresis and/or
- Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L)
and an abnormal serum FLC ratio (<0.26 or >1.65).
- Participant with relapsed and/or refractory MM with at least 1 prior line of therapy
and no more than 3 prior lines of therapy.
- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees
to practice complete abstinence or use approved contraception methods.
- Male participants agree to practice true abstinence or agree to use approved
contraception methods while receiving study treatment, during dose interruptions and
at least 5 months following study treatment discontinuation, even if has undergone a
successful vasectomy.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Primary refractory MM defined as participants who have never achieved at least a
minimal response (MR) with any treatment during the disease course
- Participants with prior anti-CD38 treatment if: a) administered <9 months before
first isatuximab administration or randomization as applicable or, b) Intolerant to
the anti-CD38 previously received
- Prior treatment with carfilzomib
- Known history of allergy to captisol (a cyclodextrin derivative used to solubilize
carfilzomib), prior hypersensitivity to sucrose, histidine (as base and
hydrochloride salt), polysorbate 80, or any of the components (active substance or
excipient) of study treatment that are not amenable to premedication with steroids,
or intolerance to arginine and Poloxamer 188 that would prohibit further treatment
with these agents
- Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired
immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain
(AL) amyloidosis
- Any severe acute or chronic medical condition which could impair the ability of the
participant to participate in the study or interfere with interpretation of study
results (eg, systemic infection unless specific anti-infective therapy is employed)
or participant unable to comply with the study procedures.
The above information is not intended to contain all considerations relevant to a
potential participation in a clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Investigational Site Number : 0360002
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Facility:
Name:
Investigational Site Number : 0360001
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Facility:
Name:
Hospital Mae de Deus Site Number : 0760002
Address:
City:
Porto Alegre
Zip:
90110-270
Country:
Brazil
Facility:
Name:
Clínica São Germano Site Number : 0760003
Address:
City:
Sao Paulo
Zip:
04537-081
Country:
Brazil
Facility:
Name:
Hospital das Clinicas de Sao Paulo Site Number : 0760001
Address:
City:
Sao Paulo
Zip:
05403-000
Country:
Brazil
Facility:
Name:
Investigational Site Number : 2030002
Address:
City:
Brno
Zip:
62500
Country:
Czechia
Facility:
Name:
Investigational Site Number : 2030004
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Facility:
Name:
Investigational Site Number : 2030003
Address:
City:
Ostrava - Poruba
Zip:
70852
Country:
Czechia
Facility:
Name:
Investigational Site Number : 2030001
Address:
City:
Praha 2
Zip:
12808
Country:
Czechia
Facility:
Name:
Investigational Site Number : 3000001
Address:
City:
Athens
Zip:
10676
Country:
Greece
Facility:
Name:
Investigational Site Number : 3000002
Address:
City:
Athens
Zip:
11528
Country:
Greece
Facility:
Name:
Investigational Site Number : 3000003
Address:
City:
Thessaloniki
Zip:
54007
Country:
Greece
Facility:
Name:
Investigational Site Number : 3920001
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Facility:
Name:
Investigational Site Number : 3920002
Address:
City:
Okayama-shi
Zip:
701-1192
Country:
Japan
Facility:
Name:
Investigational Site Number : 6200001
Address:
City:
Braga
Zip:
4710-243
Country:
Portugal
Facility:
Name:
Investigational Site Number : 6200004
Address:
City:
Lisboa
Zip:
1400-038
Country:
Portugal
Facility:
Name:
Investigational Site Number : 6200005
Address:
City:
Lisboa
Zip:
1649-035
Country:
Portugal
Start date:
April 5, 2023
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Sanofi
Agency class:
Industry
Source:
Sanofi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704049
