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NCT05704049 · CITED IN SOURCE DOCUMENTS

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2025-12-29

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, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. 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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Cohort 1: manual administration
    type
    EXPERIMENTAL
  2. description
    Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter, in combination with carfilzomib and dexamethasone. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 1 Cohort 2: manual administration
    type
    EXPERIMENTAL
  3. description
    Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    type
    EXPERIMENTAL
  4. description
    Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    type
    EXPERIMENTAL
  5. description
    Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    type
    EXPERIMENTAL
  6. description
    Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    type
    EXPERIMENTAL
  7. description
    Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    type
    EXPERIMENTAL
  8. description
    Isatuximab will be administered in combination with carfilzomib and dexamethasone. Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. From Cycle 7 and onwards, participants can choose manual or OBDS. Participants may receive other treatments as rescue medication or background medication.
    intervention Names
    1. Drug: Isatuximab
    2. Drug: Carfilzomib
    3. Drug: Dexamethasone
    4. Drug: Dexamethasone IV
    5. Drug: Montelukast
    6. Drug: Acetaminophen
    7. Drug: Diphenhydramine
    8. Drug: Methylprednisolone
    label
    Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous
    name
    Isatuximab
    type
    DRUG
  2. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
    name
    Carfilzomib
    other Names
    1. Kyprolis
    type
    DRUG
  3. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral
    name
    Dexamethasone
    type
    DRUG
  4. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
    name
    Dexamethasone IV
    type
    DRUG
  5. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral
    name
    Montelukast
    type
    DRUG
  6. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)
    name
    Acetaminophen
    type
    DRUG
  7. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV
    name
    Diphenhydramine
    type
    DRUG
  8. arm Group Labels
    1. Cohort 1: manual administration
    2. Part 1 Cohort 2: manual administration
    3. Part 2 Cohort 3 Randomized Cohort: Manual to OBDS
    4. Part 2 Cohort 3 Randomized Cohort: OBDS to manual
    5. Part 3 Cohort 4 Randomized Cohort: OBDS to manual
    6. Part 3 Cohort 4: Randomized Cohort: manual to OBDS
    7. Part 3 Cohort 5 Randomized Cohort: OBDS to manual administration in Chinese participants
    8. Part 3 Cohort 5 Randomized Cohort: manual to OBDS administration in Chinese participants
    description
    Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV
    name
    Methylprednisolone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
118
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
    measure
    Overall response rate (ORR) - Cohorts 1 to 3
    time Frame
    6 months after the Last Participant In (LPI) i.e., approximately 16 months
  2. measure
    Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5
    time Frame
    Cycle 1 (28 days)
  3. measure
    Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5
    time Frame
    Cycle 1 (28 days)
secondary Outcomes
  1. description
    Patient preference for method of administration defined as the proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6 using the patient experience and satisfaction questionnaire version 2 (PESQ v2).
    measure
    Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6
    time Frame
    6 months from LPI i.e., approximately 16 months
  2. measure
    Incidence rate of infusion reactions (IRs)
    time Frame
    From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
  3. measure
    Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters
    time Frame
    From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months
  4. measure
    Incidence rate of injection site reactions (ISRs)
    time Frame
    18 months after LPI i.e., approximately 28 months
  5. description
    Blood samples will be collected for measurement of isatuximab concentrations.
    measure
    PK concentration: trough plasma concentration (Ctrough)
    time Frame
    Cycle 2 Day 1 and Cycle 6 Day 1 (1 Cycle = 28 days)
  6. description
    Proportion of participants with sCR, CR, VGPR, and PR according to the 2016 IMWG criteria assessed by investigator.
    measure
    Overall response rate (ORR)
    time Frame
    6 months after the Last Participant In (LPI) i.e., approximately 16 months
  7. description
    DOR defined as time from date of first IRC-determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by IRC or death, whichever occurred first, for Cohorts 1 to 3. For Cohorts 4-5, the time from date of first investigator determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first.
    measure
    Duration of response (DOR)
    time Frame
    6 months after the Last Participant In (LPI) i.e., approximately 16 months
  8. description
    TT1R defined as time from first investigational medicinal product (IMP) administration or randomization to first IRC determined response (PR or better) that is subsequently confirmed, for Cohorts 1 to 3. For cohorts 4-5, the time from first IMP administration or randomization to first investigator determined response (PR or better) that is subsequently confirmed.
    measure
    Time to first response (TT1R)
    time Frame
    6 months after the Last Participant In (LPI) i.e., approximately 16 months
  9. description
    TTBR defined as time from first IMP administration or randomization to first occurrence of IRC determined best response (PR or better) that is subsequently confirmed, for Cohorts 1 to 3. For cohorts 4-5, the time from first IMP administration or randomization to first occurrence of investigator determined best response (PR or better) that is subsequently confirmed.
    measure
    Time to best response (TTBR)
    time Frame
    6 months after the Last Participant In (LPI) i.e., approximately 16 months
  10. description
    PFS defined as time from the date of first IMP administration or randomization to the date of first documentation of PD as determined by IRC for Cohorts 1 to 3 and by Investigator for all cohorts, or the date of death from any cause, whichever comes first.
    measure
    Progression free survival (PFS)
    time Frame
    18 months after LPI i.e., approximately 28 months
  11. description
    OS defined as time from the date of first IMP administration or randomization to death from any cause.
    measure
    Overall survival (OS)
    time Frame
    18 months after LPI i.e., approximately 28 months
  12. measure
    Incidence of participants with anti-drug antibodies (ADA) against isatuximab
    time Frame
    From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e., approximately 13 months (1 Cycle = 28 days)
Full study description
brief 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, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. 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.
Source references
references
  1. citation
    Parmar G, Capra M, Seguro F, Hungria V, Dimopoulos MA, Delimpasi S, Minarik J, Spicka I, Pour L, Marques H, Esteves G, Sunami K, Yuda J, Hajek R, Mihalyova J, Soufflet C, Yu D, Benlhassan K, Koch V, Comerford E, Cordero P, Suzan F, Quach H. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025 Dec 27;16(1):16. doi: 10.1038/s41408-025-01436-0.
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        3 (90% CI: 1.32-1.78).</p><p>Efficacy of isatuximab-irfc administered subcutaneously in combination with carfilzomib and dexamethasone was evaluated in IZALCO (NCT05704049), in 74 patients in a phase 2 clinical study in patients with relapsed and/or refractory multiple myeloma. The efficacy outcome measure, ORR by IRC, was 79.7%
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      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
      spl effective time
      20260710
      spl set id
      07730e8c-1340-4d30-8d71-e20f850db8da

    Preserved source evidence · Not medical advice