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Multiple MyelomaPhase 1/2IslandsNCT02812706

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients

A Phase 1/2 study testing Isatuximab SAR650984 in people with Multiple Myeloma, run by Sanofi at 13 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objectives: Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma. Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Isatuximab SAR650984
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
13 sitesJapan
Study dates
5 Sep 2016to 28 Sep 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females, age 20 years or older.
  • Participants had a known diagnosis of symptomatic multiple myeloma.
  • Participants had received at least 3 prior lines of therapies OR participants whose disease was double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI).
  • Participants had been responsive (i.e., minimal response [MR] or better) to at least one prior line of therapy.
  • Refractory to the most recently received IMiD or PI included therapy.
  • Participants with measurable disease defined as at least one of the following:
Show all 10Show fewer
  • Immunoglobulin G (IgG) Type: Serum M-protein >=1 gram per deciliter (g/dL) (>=10 g/L);
  • Immunoglobulin A (IgA) and D Type: Serum M-protein, quantification should be performed;
  • Urine M-protein ≥200 mg/24 hours.
  • Participants with a Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Who cannot join

  • Participants treated with any anti-CD38 agent.
  • Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
  • Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below:
  • Alkylating agents (e.g., Melphalan) within 28 days prior to the first dose of study treatment.
  • Steroids treatment (e.g., prednisone greater than (>)10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment.
  • Participated in another clinical trial within 30 days prior to the first dose of study treatment.
Show all 21Show fewer
  • Participants treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment.
  • Major surgical procedure within 4 weeks prior to the first dose of study treatment.
  • Any toxicity Grade >=2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
  • Neuropathy Grade >=3 or painful peripheral neuropathy Grade >=2.
  • History of significant cardiovascular disease unless the disease within the past 6 months was well-controlled.
  • Previously received an allogenic stem cell transplant.
  • Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia.
  • Participants with known or suspected amyloidosis.
  • Participants with Waldenstrom's macroglobulinemia OR Multiple myeloma IgM subtype.
  • Participants with active infection.
  • Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.
  • Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
  • Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.
  • Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Japan13 sites

  • Investigational Site Number :392012

    Chuo-ku, Tokyo, 104-0045

  • Investigational Site Number :392010

    Hiroshima, Hiroshima, 730-8619

  • Investigational Site Number :392015

    Kanazawa, Ishikawa-ken, 920-8641

  • Investigational Site Number :392016

    Kyoto, Kyoto, 603-8151

  • Investigational Site Number :392001

    Nagoya, Aichi-ken, 467-8602

  • Investigational Site Number :392003

    Okayama, Okayama-ken, 701-1192

  • Investigational Site Number :392009

    Osaka, Osaka, 543-8555

  • Investigational Site Number :392005

    Shibukawa-shi, Gunma, 377-0280

  • Investigational Site Number :392002

    Shibuya-ku, Tokyo, 150-8935

  • Investigational Site Number :392013

    Suita-shi, Osaka, 565-0871

  • Investigational Site Number :392017

    Sunto-gun, Shizuoka, 411-8777

  • Investigational Site Number :392008

    Suwa-shi, Nagano, 392-8510

  • Investigational Site Number :392011

    Yamagata, 990-9585

Other trials in Japan

About this study

Official title: A Phase I/II Study of Isatuximab (Anti-CD38 mAb) Administered as a Single Agent in Japanese Patients With Relapsed and Refractory Multiple Myeloma

Primary Objectives:

  • Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
  • Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.
Read more

Secondary Objectives:

  • To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed.
  • To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.
  • To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.
  • To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.
Read the detailed description

The study duration for an individual participant included a screening period for inclusion of up to 21 days, the treatment period consisting of 28-day cycles and a follow-up period. Treatment with isatuximab might continue until disease progression, unacceptable adverse event, or other reason for discontinuation.

Being tested
Isatuximab SAR650984
Keywords
Anti-CD38 monoclonal antibody
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isatuximab SAR650984Drug

    Also called Sarclisa

    Pharmaceutical form: solution Route of administration: intravenous

Study groups in NCT02812706
Study groupRoleWhat they receive
Phase 1, Cohort 1: Isatuximab 10 mg/kgExperimentalParticipants received Isatuximab 10 milligram per kilogram (mg/kg) intravenous (IV) infusion once every week (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then every 2 weeks (Q2W) (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
Receives: Drug: Isatuximab SAR650984
Phase 1, Cohort 2: Isatuximab 20 mg/kgExperimentalParticipants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
Receives: Drug: Isatuximab SAR650984
Phase 2: Isatuximab 20 mg/kgExperimentalParticipants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).
Receives: Drug: Isatuximab SAR650984

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

    DLTs: AEs occurring during 1st treatment cycle, assessed per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs included: Hematologic DLTs: Grade(G) 4 neutropenia(N) lasting greater than or equal to (>=) 5 days; G3 to G4 N with fever or microbiologically or radiographically documented infection; G4 thrombocytopenia lasting for >=5 days; thrombocytopenia, treatment delay greater than (>)14 days due to hematologic toxicity. Non-hematologic DLTs: G>=3 non-hematological AE, excluding G3 fatigue, G 3 to 4 electrolyte abnormalities, G3 nausea/vomiting/diarrhea if responsive to optimal medical management within 48 hours or allergic reaction/ hypersensitivity attributed to isatuximab; AE that required treatment delay for >14 days. Any other toxicity deemed by Investigator or sponsor to be dose-limiting, regardless of the grade, was also considered DLT.

    Measured: Cycle 1 (28 days)

  2. Phase 2: Percentage of Participants With Overall Response (OR)

    Percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed by International Myeloma Working Group (IMWG) uniform response criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; <5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h; >90% decrease in difference between involved \& uninvolved FLC levels required. PR: >=50% reduction of serum M-protein \& reduction in 24h urinary M protein by >=90%/<200 mg/24 h; if serum \& urine M-protein unmeasurable:>=50% decrease in difference between involved \& uninvolved FLC; if serum \& urine M-protein not measurable:>=50% reduction in plasma cells required, in place of M-protein.

    Measured: From the date of the first response until the primary analysis data cut-off date of 31 July 2018 (median duration of follow-up was 24.14 weeks)

Secondary outcomes (20)

  1. Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).

    Measured: From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)

  2. Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs are defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).

    Measured: From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 248 weeks)

  3. Phase 1: Percentage of Participants With Overall Response (OR)

    Percentage of participants with sCR, CR, VGPR, and PR assessed by IMWG uniform response criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; <5 percentage (%) plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour (h); >90% decrease in difference between involved \& uninvolved FLC levels required. PR: >=50% reduction of serum M-protein \& reduction in 24h urinary M protein by >=90%/<200 mg/24 h; if serum \& urine M-protein unmeasurable:>=50% decrease in difference between involved \& uninvolved FLC; if serum \& urine M-protein not measurable:>=50% reduction in plasma cells required, in place of M-protein.

    Measured: From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)

  4. Phase 1: Duration of Response (DOR)

    DOR: time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): increase (inc.) of >=25% from lowest response value in any one of following: serum M-component (absolute inc.>=0.5 g/dL) and/or; urine M-component (absolute inc.>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein: difference between involved \& uninvolved FLC levels (absolute inc. >10 mg/dL); in participants without measurable serum \& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute % >=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.

    Measured: From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)

  5. Phase 2: Percentage of Participants With Clinical Benefit (CB)

    CB defined as percentage of participants with sCR, CR, VGPR, PR or Minor/minimal response (MR) assessed by IMWG criteria. sCR: CR as defined plus normal FLC ratio \& absence of clonal cells. CR: negative immunofixation on serum \& urine; disappearance of any soft tissue plasmacytomas; <5% plasma cells in bone marrow; normal FLC ratio: 0.26-1.65. VGPR: serum \& urine M-protein detectable by immunofixation; >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24h; >90% decrease in difference between involved \& uninvolved FLC levels required. PR: >=50% reduction of serum M-protein \& reduction in 24h urinary M protein by >=90%/<200 mg/24 h; if serum \& urine M-protein unmeasurable:>=50% decrease in difference between involved \& uninvolved FLC; if serum \& urine M-protein not measurable:>=50% reduction in plasma cells required. MR: >=25% but <=49% reduction of serum M protein and reduction in 24h urine M protein by 50-89%; 25-49% reduction in size of soft tissue plasmacytomas.

    Measured: From date of first study treatment administration until first documented response, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)

  6. Phase 2: Overall Survival (OS)

    Overall survival was defined as the time interval (in months) from the date of first study treatment administration to death due to any cause. In the absence of the confirmation of death before the cut-off date, OS was censored at the last date the participant was known to be alive or at the study cut-off date, whichever was earlier. Analysis was performed by Kaplan-Meier method.

    Measured: From date of first study treatment administration to the date of death due to any cause (maximum duration of exposure: up to 248 weeks)

  7. Phase 2: Progression Free Survival (PFS)

    PFS was defined as the time interval (in months) from date of first study treatment administration until disease progression or death due to any cause, whichever comes first. In absence of PD or death, PFS was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of >=25% in any one of following: serum M-component absolute (abs.) inc. >=0.5 g/dL) and/or; urine M-component (abs. inc. >=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein, difference between involved \& uninvolved FLC levels (abs. inc. >10 mg/dL); in participants without measurable serum \& urine M-protein \& without measurable disease by FLC levels: bone marrow plasma cell % (abs. % >=10%); definite development of new bone lesions or soft tissue plasmacytomas or definite inc. in size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia.

    Measured: From date of first study treatment administration until disease progression or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)

  8. Phase 2: Duration of Response (DOR)

    DOR was defined as time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria):inc. of >=25% from lowest response value in any one of following: serum M-component (absolute inc.>=0.5 g/dL) and/or; urine M-component (absolute inc.>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein: difference between involved \& uninvolved FLC levels (absolute inc.>10 mg/dL); in participants without measurable serum \& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% >=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.

    Measured: From the date of first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)

  9. Phase 2: Time to Progression (TTP)

    TTP: time interval (in months) from date of first study treatment administration to date of first assessed disease progression. In absence of disease progression, TTP was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of >=25% from lowest response value in any one of following: serum M-component (absolute inc.>=0.5 g/dL) and/or; urine M-component (absolute inc.>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein: difference between involved \& uninvolved FLC levels (absolute inc.>10 mg/dL); in participants without measurable serum \& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% >=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.

    Measured: From date of first study treatment administration until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)

  10. Phase 1: Plasma Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab

    Ceoi is the plasma concentration observed at the end of intravenous infusion.

    Measured: End of infusion on Day 1 of Cycle 1

  11. Phase 1: Maximum Observed Concentration (Cmax) After First Infusion of Isatuximab

    Cmax was defined as the maximum concentration observed after the first infusion calculated using the non-compartmental analysis.

    Measured: Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), end of infusion (EOI) and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)

  12. Phase 1: Time to Reach the Maximum Concentration (Tmax) After First Infusion of Isatuximab

    Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion.

    Measured: Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)

  13. Phase 1: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-week) After First Infusion of Isatuximab

    AUC was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval.

    Measured: Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)

  14. Phase 1: Trough Plasma Concentrations (Ctrough) of Isatuximab

    Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.

    Measured: Pre-infusion on Cycle 1 Day 8 (C1 D8), C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15, C11 D1

  15. Phase 2: Maximum Observed Concentration (Cmax) After First Infusion of Isatuximab

    Cmax was predicted using population pharmacokinetic model.

    Measured: Multiple timepoints from Cycle 1 to Cycle 10

  16. Phase 2: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-Week) After First Infusion of Isatuximab

    AUC was predicted using population pharmacokinetic model.

    Measured: Multiple timepoints from Cycle 1 to Cycle 10

  17. Phase 2: Trough Plasma Concentrations (Ctrough) of Isatuximab

    Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.

    Measured: Pre-infusion on C1 D8, C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15

  18. Phase 1 and 2: CD38 Receptor Density at Baseline

    CD38 receptor density assessed from bone marrow aspirates for responder and non-responders' participants was reported.

    Measured: At Baseline (Day 1)

  19. Phase 1: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab

    ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \& posttreatment samples of at least two titer steps, during the ADA on-study observation period.

    Measured: From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2)

  20. Phase 2: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab

    ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \& posttreatment samples of at least two titer steps, during the ADA on-study observation period.

    Measured: From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 248 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2016 (estimated)
  2. Study start5 Sep 2016
  3. Primary completion31 Jul 2018
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02812706
Sponsor's protocol ID
TED14095
Other IDs
U1111-1175-0679
Acronym
Islands
Status last verified
Sep 2023
First submitted
22 Jun 2016
Last updated
1 Apr 2024
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Sunami K, Fuchida SI, Suzuki K, Ri M, Matsumoto M, Shimazaki C, Asaoku H, Shibayama H, Ishizawa K, Takamatsu H, Ikeda T, Maruyama D, Imada K, Uchiyama M, Kiguchi T, Iyama S, Murakami H, Onishi R, Tada K, Iida S. Anti-CD38 antibody isatuximab monotherapy for Japanese individuals with relapsed/refractory multiple myeloma: An update of the phase 1/2 ISLANDs study. Hematol Oncol. 2023 Aug;41(3):442-452. doi: 10.1002/hon.3105. Epub 2022 Dec 15.

    PubMed 36433829

  • Sunami K, Suzuki K, Ri M, Matsumoto M, Shimazaki C, Asaoku H, Shibayama H, Ishizawa K, Takamatsu H, Ikeda T, Maruyama D, Kaneko H, Uchiyama M, Kiguchi T, Iyama S, Murakami H, Takahashi K, Tada K, Mace S, Guillemin-Paveau H, Iida S. Isatuximab monotherapy in relapsed/refractory multiple myeloma: A Japanese, multicenter, phase 1/2, safety and efficacy study. Cancer Sci. 2020 Dec;111(12):4526-4539. doi: 10.1111/cas.14657. Epub 2020 Oct 15.

    PubMed 32975869

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Isatuximab SAR650984 in people with Multiple Myeloma, run by Sanofi at 13 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02812706, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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