Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

NCT01084252 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: TED10893U1111-1116-54722013-001418-13
• Study Type: interventional
• Target: 351
• Locations: 17 countries
• Sites: 59

Brief Summary

Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1:

• To characterize the global safety profile including cumulative toxicities.
• To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s).
• To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:
• Safety
• Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):
• Safety
• Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.
• Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status.
• Pharmacokinetic profile of Isatuximab.
• Immunogenicity of Isatuximab.
• Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.

Conditions

Hematological Malignancy

Keywords

Anti-CD38 monoclonal antibody

Outcome Measures

Primary Outcomes (4)

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

  DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT.

  Day 1 of Cycle 1 up to Day 14 of Cycle 2

• Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.

  From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )

• Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria

  OR defined as participants with stringent complete response (sCR) or complete response (CR) or very good partial response (VGPR) or partial response (PR) . Based on IMWG, CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow; sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; PR: \>=50% reduction of serum M-Protein and reduction in urinary M-protein by \>=90% or to \<200 mg/24 hours; \>=50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a \>=50% reduction in plasma cells in place of M-protein if present at baseline.

  From the date of randomization until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for Stage 1b arm)

• Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria

  OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours, \>90% decrease in the difference between involved and uninvolved FLC levels; PR: \>=50% reduction of serum M-Protein and reduction in urinary M-protein by \>=90% or to \<200 mg/24 hours; \>=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or \>=50% reduction in plasma cells in place of M-protein if present at baseline.

  From the date of randomization to date of death from any cause (maximum duration: 97 weeks)

Secondary Outcomes (32)

• Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)

  Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion

• PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab

  For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion

• PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab

  For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion

• PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3

  Week 1, 2 and 3

• PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W)

  For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion

Study Arms (14)

Phase 1:Isatuximab <=1 mg/kg Q2W

EXPERIMENTAL

Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (\<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 1: Isatuximab 3mg/kg Q2W

EXPERIMENTAL

Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 1: Isatuximab 5 mg/kg Q2W

EXPERIMENTAL

Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)

EXPERIMENTAL

Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 1:Isatuximab (CD38 + HM and High Risk Multiple Myeloma)

EXPERIMENTAL

Participants with CD38+ HM along with participants with high risk multiple myeloma, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 1: Isatuximab 10 mg/kg QW

EXPERIMENTAL

Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 1: Isatuximab 20 mg/kg Q2W

EXPERIMENTAL

Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 1: Isatuximab 20 mg/kg QW

EXPERIMENTAL

Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).

Drug: Isatuximab SAR650984

Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W

EXPERIMENTAL

Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable adverse event (AE), disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).

Drug: Isatuximab SAR650984

Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W

EXPERIMENTAL

Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).

Drug: Isatuximab SAR650984

Phase2 Stage1a:Isatuximab 10mg/kg Q2W; Then Q4W

EXPERIMENTAL

Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 week (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).

Drug: Isatuximab SAR650984

Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W

EXPERIMENTAL

Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).

Drug: Isatuximab SAR650984

Phase 2 Stage 2: Isatuximab Alone

EXPERIMENTAL

Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).

Drug: Isatuximab SAR650984

Phase 2 Stage 2: Isatuximab + Dexamethasone

EXPERIMENTAL

Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than \[\<\] 75 years of age; 20 mg/day \[greater than or equal to \[\>=\] for 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).

Drug: Isatuximab SAR650984; Drug: Dexamethasone

Interventions

Isatuximab SAR650984 DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Also known as: Sarclisa

Phase 1: Isatuximab 10 mg/kg QW; Phase 1: Isatuximab 20 mg/kg Q2W; Phase 1: Isatuximab 20 mg/kg QW; Phase 1: Isatuximab 3mg/kg Q2W; Phase 1: Isatuximab 5 mg/kg Q2W; Phase 1:Isatuximab (CD38 + HM and High Risk Multiple Myeloma); Phase 1:Isatuximab <=1 mg/kg Q2W; Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W; Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W; Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W; Phase 2 Stage 2: Isatuximab + Dexamethasone; Phase 2 Stage 2: Isatuximab Alone; Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma); Phase2 Stage1a:Isatuximab 10mg/kg Q2W; Then Q4W

Dexamethasone DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Phase 2 Stage 2: Isatuximab + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1:
• For dose escalation cohorts, participants with confirmed selected CD38+ hematological malignancies as specified below who had progressed on after standard therapy or for whom there was no effective standard therapy (refractory/relapsed participants). B-cell Non-Hodgkin-lymphoma/leukemia (NHL) participants with at least 1 measurable lesion. Multiple myeloma (MM) participants with measurable M-protein serum and/or 24-hour urine. Acute myeloid leukemia (AML) participants, all types except M3 based on French-American-British (FAB) classification. Acute Lymphoblastic Leukemia (B-cell ALL) participants. Chronic lymphocytic leukemia (CLL) participants.
• For expansion cohorts, participants with relapsed/refractory MM with measurable M-protein (serum M-protein of \>0.5 g/dL and/or urine M-protein of \>200 mg (24-hr urine)) or elevated serum free light chains (FLC) \>10 mg/dL with abnormal FLC ratio) who had progressed on or after standard therapy that included an Immunomodulatory drug (IMiD) and a proteasome inhibitor and who met the protocol defined criteria for standard risk or high risk.
• Phase 2:
• Participants had a known diagnosis of multiple myeloma with evidence of measurable disease, and have evidence of disease progression based on International Myeloma Working Group (IMWG) criteria: Serum M-protein ≥1 g/dL, or urine M-protein \>=200 mg/24 hours or in the absence of measurable m-protein, serum FLC \>=10 mg/dL, and abnormal serum immunoglobulin kappa lambda FLC ratio (\<0.26 or \>1.65).
• Participants who received at least three prior lines of therapy for MM and had treatment with an IMiD (for \>=2 cycles or \>=2 months of treatment) and a proteasome inhibitor (PI) (for \>=2 cycles or \>=2 months of treatment) OR participants whose disease was double refractory to an IMiD and a PI. For participants who had received more than 1 type of IMiD and PI, their disease must be refractory to the most recent one.
• Participants who had achieved a minimal response or better to at least one prior line of therapy.
• Participants who had received an alkylating agent (\>=2 cycles or \>=2 months) either alone or in combination with other MM treatments.
• Stage 2 only: Participants who had evidence of disease progression on or after the most recent prior regimen based on IMWG criteria.

You may not qualify if:

• Phase 1:
• Karnofsky performance status \<60
• Poor bone marrow reserve
• Poor organ function
• Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of the study therapy that was not amenable to pre-medication with steroids and H2 blockers
• Any serious active disease (including clinically significant infection that was chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, interfered with the safety, the compliance with the study or with the interpretation of the results
• 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
• Phase 2:
• Participants with multiple myeloma immunoglobulin M (IgM) subtype
• Previous treatment with any anti-CD38 therapy
• Participants with concurrent plasma cell leukemia
• Participants with known or suspected amyloidosis
• Karnofsky performance status \<60 (stage 1)/Eastern Cooperative Oncology Group (ECOG) Performance status \>2 (stage 2).
• Poor bone marrow reserve
• Poor organ function

Sponsors & Collaborators

• Sanofi: lead

Study Sites (59)

Mayo Clinic Site Number : 840003

Scottsdale, Arizona, 85054, United States

Location

UCSF MS Center Site Number : 840005

San Francisco, California, 94117, United States

Location

Emory University Site Number : 840009

Atlanta, Georgia, 30322, United States

Location

University of Chicago Site Number : 840010

Chicago, Illinois, 60637, United States

Location

The University Of Michigan Site Number : 840022

Ann Arbor, Michigan, 48109-0759, United States

Location

Karmanos Cancer Center Site Number : 840027

Detroit, Michigan, 48201, United States

Location

Mayo Clinic of Rochester Site Number : 840018

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine Site Number : 840013

St Louis, Missouri, 63110, United States

Location

The Cancer Center At Hackensack University Medical Site Number : 840011

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan-Kettering Cancer Center Site Number : 840014

New York, New York, 10021, United States

Location

Duke University Medical College Site Number : 840016

Durham, North Carolina, 27707, United States

Location

University of Cincinnati Site Number : 840004

Cincinnati, Ohio, 45267-0542, United States

Location

Vanderbilt University Site Number : 840001

Nashville, Tennessee, 37232, United States

Location

Huntsman Cancer Institute at the University of Utah Site Number : 840002

Salt Lake City, Utah, 84112-5550, United States

Location

Fred Hutchinson Cancer Research Center Site Number : 840012

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin Site Number : 840017

Milwaukee, Wisconsin, 53226, United States

Location

Investigational Site Number : 032003

Capital Federal, Buenos Aires, C1425ASS, Argentina

Location

Investigational Site Number : 032002

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Investigational Site Number : 032001

Ciudad de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Investigational Site Number : 056001

Antwerp, 2060, Belgium

Location

Hospital Mae de Deus Site Number : 076003

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 076001

Barretos, São Paulo, 14784-400, Brazil

Location

Clínica São Germano Site Number : 076002

São Paulo, São Paulo, 04537-081, Brazil

Location

Instituto COI de Educacao e Pesquisa Site Number : 076004

Rio de Janeiro, 22775-002, Brazil

Location

Investigational Site Number : 152001

Temuco, La Araucanía, 4810469, Chile

Location

Investigational Site Number : 246001

Helsinki, 00029, Finland

Location

Investigational Site Number : 246002

Turku, 20520, Finland

Location

Investigational Site Number : 250003

Nantes, 44093, France

Location

Investigational Site Number : 250004

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 250001

Toulouse, 31059, France

Location

Investigational Site Number : 300001

Athens, 11528, Greece

Location

Investigational Site Number : 376004

Jerusalem, 91120, Israel

Location

Investigational Site Number : 376002

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number : 380001

Bologna, 40138, Italy

Location

Investigational Site Number : 380002

Torino, 10126, Italy

Location

Investigational Site Number : 484003

San Luis Potosí City, San Luis Potosí, 78419, Mexico

Location

Investigational Site Number : 484001

Monterrey, 64460, Mexico

Location

Investigational Site Number : 604001

Arequipa, Peru

Location

Investigational Site Number : 604002

Lima, 34, Peru

Location

Investigational Site Number : 643002

Moscow, 125284, Russia

Location

Investigational Site Number : 643003

Novosibirsk, 630087, Russia

Location

Investigational Site Number : 643001

Petrozavodsk, 185019, Russia

Location

Investigational Site Number : 643004

Saint Petersburg, 194291, Russia

Location

Investigational Site Number : 724005

Barcelona, Barcelona [Barcelona], 08036, Spain

Location

Investigational Site Number : 724007

Badalona, Catalunya [Cataluña], 08916, Spain

Location

Investigational Site Number : 724002

Pamplona, Navarre, 31008, Spain

Location

Investigational Site Number : 724006

Valencia, Valenciana, Comunidad, 46017, Spain

Location

Investigational Site Number : 724004

Madrid, 28041, Spain

Location

Investigational Site Number : 724001

Salamanca, 37007, Spain

Location

Investigational Site Number : 724008

Seville, 41013, Spain

Location

Investigational Site Number : 792002

Ankara, 06200, Turkey (Türkiye)

Location

Investigational Site Number : 792005

Ankara, 06500, Turkey (Türkiye)

Location

Investigational Site Number : 792001

Istanbul, Turkey (Türkiye)

Location

Investigational Site Number : 792004

Samsun, 55139, Turkey (Türkiye)

Location

Investigational Site Number : 804001

Kyiv, 04112, Ukraine

Location

Investigational Site Number : 804004

Vinnytsia, 21001, Ukraine

Location

Investigational Site Number : 804002

Zaporizhzhya, 69600, Ukraine

Location

Investigational Site Number : 826002

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Investigational Site Number : 826001

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (2)

• Dimopoulos M, Bringhen S, Anttila P, Capra M, Cavo M, Cole C, Gasparetto C, Hungria V, Jenner M, Vorobyev V, Ruiz EY, Yin JY, Saleem R, Hellet M, Mace S, Paiva B, Vij R. Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma. Blood. 2021 Mar 4;137(9):1154-1165. doi: 10.1182/blood.2020008209.

  PMID: 33080623 DERIVED

• Mikhael J, Richter J, Vij R, Cole C, Zonder J, Kaufman JL, Bensinger W, Dimopoulos M, Lendvai N, Hari P, Ocio EM, Gasparetto C, Kumar S, Oprea C, Chiron M, Brillac C, Charpentier E, San-Miguel J, Martin T. A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma. Leukemia. 2020 Dec;34(12):3298-3309. doi: 10.1038/s41375-020-0857-2. Epub 2020 May 14.

  PMID: 32409691 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

isatuximab; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: May 11, 2010
• Primary Completion: December 21, 2018
• Study Completion: July 13, 2023
• Last Updated: November 1, 2024
• Results First Posted: April 15, 2020

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); RU (4); BR (4); ME (2); ES (7); BE (1); CL (1); FI (2); US (16); GR (1); TU (4); AR (3); UA (3); FR (3); IL (2); IT (2); PE (2)