search
Back to results

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Primary Purpose

Plasma Cell Myeloma Recurrent

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Isatuximab IV
Isatuximab SC
Dexamethasone
Pomalidomide
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasma Cell Myeloma Recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65))

Exclusion Criteria:

  • Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2
  • Primary refractory multiple myeloma participants
  • Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or intolerant to anti-CD38 mAb agents
  • Prior therapy with pomalidomide
  • Participants with inadequate biological tests.
  • Significant cardiac dysfunction
  • Participants diagnosed or treated for another cancer within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
  • Concomitant plasma cell leukemia
  • Active primary amyloid-light (AL) amyloidosis
  • Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
  • Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
  • Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Sites / Locations

  • Arizona Oncology Associates, PC - HAL-Site Number:8400015Recruiting
  • Mayo Clinic-Site Number:8400008Recruiting
  • Hattiesburg Clinic-Site Number:8400006Recruiting
  • New York Oncology Hematology, P.C.-Site Number:8400017Recruiting
  • Novant Health-Site Number:8400014Recruiting
  • Oncology_Hematology Care Clinical Trials, LLC-Site Number:8400016Recruiting
  • Oncology Associates Of Oregon, P.C.-Site Number:8400018Recruiting
  • George E. Wahlen Salt Lake City VA Medical Center-Site Number:8400011Recruiting
  • UW Cancer Center at ProHealth Care-Site Number:8400001Recruiting
  • Investigational Site Number :0320007Recruiting
  • Investigational Site Number :0320001Recruiting
  • Investigational Site Number :0320002Recruiting
  • Investigational Site Number :0320006Recruiting
  • Investigational Site Number :0320008Recruiting
  • Investigational Site Number :0320005Recruiting
  • Investigational Site Number :0320004Recruiting
  • Investigational Site Number :0360007Recruiting
  • Investigational Site Number :0360004Recruiting
  • Investigational Site Number :0360003Recruiting
  • Investigational Site Number :0360008Recruiting
  • Investigational Site Number :0360009Recruiting
  • Investigational Site Number :0360006Recruiting
  • Investigational Site Number :0360001Recruiting
  • Investigational Site Number :0760003Recruiting
  • Investigational Site Number :0760002Recruiting
  • Investigational Site Number :0760001Recruiting
  • Investigational Site Number :0760004Recruiting
  • Investigational Site Number :1240001Recruiting
  • Investigational Site Number :1240004Recruiting
  • Investigational Site Number :1240003Recruiting
  • Investigational Site Number :1520002Recruiting
  • Investigational Site Number :1520003Recruiting
  • Investigational Site Number :1520005Recruiting
  • Investigational Site Number :1520004Recruiting
  • Investigational Site Number :1520001Recruiting
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :1560022Recruiting
  • Investigational Site Number :1560010Recruiting
  • Investigational Site Number :1560006Recruiting
  • Investigational Site Number :1560002Recruiting
  • Investigational Site Number :1560020Recruiting
  • Investigational Site Number :1560019Recruiting
  • Investigational Site Number :1560011Recruiting
  • Investigational Site Number :1560017Recruiting
  • Investigational Site Number :1560013Recruiting
  • Investigational Site Number :1560021Recruiting
  • Investigational Site Number :1560007Recruiting
  • Investigational Site Number :1560009Recruiting
  • Investigational Site Number :1560018Recruiting
  • Investigational Site Number :1560003Recruiting
  • Investigational Site Number :1560008Recruiting
  • Investigational Site Number :1560004Recruiting
  • Investigational Site Number :2500006Recruiting
  • Investigational Site Number :2500002Recruiting
  • Investigational Site Number :2500005Recruiting
  • Investigational Site Number :2500004Recruiting
  • Investigational Site Number :2500001Recruiting
  • Investigational Site Number :2500003Recruiting
  • Investigational Site Number :2500007Recruiting
  • Investigational Site Number :2760005Recruiting
  • Investigational Site Number :3000002Recruiting
  • Investigational Site Number :3000001Recruiting
  • Investigational Site Number :3000005Recruiting
  • Investigational Site Number :3000003Recruiting
  • Investigational Site Number :3480002Recruiting
  • Investigational Site Number :3480004Recruiting
  • Investigational Site Number :3480003Recruiting
  • Investigational Site Number :3480008Recruiting
  • Investigational Site Number :3480005Recruiting
  • Investigational Site Number :3480006Recruiting
  • Investigational Site Number :3800001Recruiting
  • Investigational Site Number :3800004Recruiting
  • Investigational Site Number :3800002Recruiting
  • Investigational Site Number :3800005Recruiting
  • Investigational Site Number :3800003Recruiting
  • Investigational Site Number :3920007Recruiting
  • Investigational Site Number :3920005Recruiting
  • Investigational Site Number :3920010Recruiting
  • Investigational Site Number :3920012Recruiting
  • Investigational Site Number :3920003Recruiting
  • Investigational Site Number :3920006Recruiting
  • Investigational Site Number :3920002Recruiting
  • Investigational Site Number :3920011Recruiting
  • Investigational Site Number :3920008Recruiting
  • Investigational Site Number :3920004Recruiting
  • Investigational Site Number :3920009Recruiting
  • Investigational Site Number :5780001Recruiting
  • Investigational Site Number :6160004Recruiting
  • Investigational Site Number :6160005Recruiting
  • Investigational Site Number :6160001Recruiting
  • Investigational Site Number :7240003Recruiting
  • Investigational Site Number :7240004Recruiting
  • Investigational Site Number :7240007Recruiting
  • Investigational Site Number :7240001Recruiting
  • Investigational Site Number :7240005Recruiting
  • Investigational Site Number :7240006Recruiting
  • Investigational Site Number :7240002Recruiting
  • Investigational Site Number :7520001Recruiting
  • Investigational Site Number :1580002Recruiting
  • Investigational Site Number :8260005Recruiting
  • Investigational Site Number :8260001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isatuximab Subcutaneous (SC)

Isatuximab Intravenous (IV)

Arm Description

Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).

Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
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 IMWG criteria assessed by Independent Review Committee (IRC).
Observed concentration before dosing (Cthrough) at steady state
Observed Isatuximab plasma concentration

Secondary Outcome Measures

Very Good Partial Response or better rate (VGPR)
Very Good Partial Response or better rate defined as the proportion of participants with stringent complete response (sCR), complete response (CR) and very good partial response (VGPR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
Observed concentration before dosing (Ctrough)
Observed Isatuximab plasma concentration
Incidence rate of infusion-reactions
Proportion of participants with infusion-reactions related events
Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
Participant's satisfaction with isatuximab subcutaneous (SC) and intravenous (IV) will be assessed based on the Patient Experience and Satisfaction Questionnaires (PESQ) questionnaire.
Duration of response (DOR)
DOR, defined as the time from the date of the first confirmed response to the date of first occurrence of progressive disease (PD) as determined by IRC or death, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better). In the absence of PD or death before the analysis cut-off date, the DOR will be censored at the date of the last valid disease assessment performed prior to initiation of a further anti-myeloma treatment or the analysis cut-off date, whichever is earlier. Participants with two or more consecutive missed assessments prior to PD or death will be censored at the last valid disease assessment.
Time to first response (TT1R)
TT1R, defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. Same censoring rule applies as in the DOR endpoint.
Time to best response (TTBR)
TTBR, defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that is subsequently confirmed. Same censoring rule applies as in the DOR endpoint
Progression free survival (PFS)
PFS, defined as the time from the date of randomization to the date of first documentation of progressive disease as determined by IRC or the date of death from any cause, whichever comes first. Responses will be determined according to IMWG criteria. Progression based on paraprotein will be confirmed based on two consecutive assessments. PFS will be censored at the date of the last valid disease assessment not showing disease progression performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. Participants with two or more consecutive missed assessments prior to PD or death will be censored at the last valid disease assessment.
Overall survival (OS)
OS, defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date will be censored at the last date the participant was known to be alive or the cut-off date, whichever is first.
Progression free survival 2 (PFS2)
PFS2, defined as time from the date of randomization to the date of first documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happens first. Same censoring rule applies as in the PFS endpoint.
Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs).
Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the treatment period. The treatment period is defined as the time from first dose of study treatment up to 30 days after last dose of study treatment.
Pharmacokinetic (PK) parameter
Maximum plasma concentration (Cmax)
PK parameter
Area under the plasma concentration time curve over the dosing period (AUC)
Successful injection rate
Number of successful injections with (investigational) isatuximab injector device divided by total number of actual injections
Percentage of participants with anti-drug antibodies (ADA) against isatuximab
An ADA positive patient was defined as a subject either having treatment-induced ADA response (no positive ADA response at baseline and any positive response in the post baseline period, including the follow-up visit) or a treatment-boosted ADA response (a positive ADA response at baseline and a ≥4-fold increase in titer in the post baseline period including the follow-up visit).
Participant expectation questionnaire-baseline (PEQ-BL) score
PEQ-BL is designed to assess the expectations of the participants regarding both the treatment (side effects, worth taking) and the administration method (confidence, comfortability, pain, side effects, potential time-savings), as well as to understand previous treatment experience from the participant (experience with injection methods for oncology medication).
Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
PESQ-FU, a 9-item questionnaire is designed to follow up on participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction).
Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
PESQ-EOT, a 17-item questionnaire is designed to assess participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction). This questionnaire includes also additional items to assess participant preference on injection method (subcutaneous or intravenous) and location of administration (at home or at clinic).
Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
Medical resource utilization and participant productivity will be collected from participants through the HRUPQ questionnaire. The questions include number, nature (emergency or routine) and duration of hospitalizations; emergency room visits and outpatient medical encounters; and employment history. The HRUPQ contains 46 items.
Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score
EORTC QLQ-C30 is a cancer-specific questionnaire that contains 30 items and provides a multidimensional assessment of Health Related Quality of Life (HRQL).
Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)
EORTC QLQ-MY20, a 20-item questionnaire is used to assess symptoms and side effects due to the treatment or the disease which impact HRQL in participants with multiple myeloma.
Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores
EQ-5D-5L questionnaire is a measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and visual analogue scale (VAS). The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the respondent's self-rated health on a 20 cm vertical, VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine.'
Number of participants with chromosomal abnormalities
Explore chromosomal abnormalities (mainly but not limited to t(4;14), t(14;16), del(17p), and 1q21+)

Full Information

First Posted
May 31, 2022
Last Updated
August 11, 2023
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT05405166
Brief Title
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Official Title
A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 11, 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
May 23, 2024 (Anticipated)
Study Completion Date
October 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Detailed Description
Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isatuximab Subcutaneous (SC)
Arm Type
Experimental
Arm Description
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).
Arm Title
Isatuximab Intravenous (IV)
Arm Type
Active Comparator
Arm Description
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).
Intervention Type
Drug
Intervention Name(s)
Isatuximab IV
Other Intervention Name(s)
SAR650984, SARCLISA®
Intervention Description
Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous
Intervention Type
Drug
Intervention Name(s)
Isatuximab SC
Other Intervention Name(s)
SAR650984
Intervention Description
Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Pharmaceutical form: Tablet; Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Pomalyst
Intervention Description
Pharmaceutical form: hard capsules; Route of administration: Oral
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
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 IMWG criteria assessed by Independent Review Committee (IRC).
Time Frame
Up to approximately 2 years
Title
Observed concentration before dosing (Cthrough) at steady state
Description
Observed Isatuximab plasma concentration
Time Frame
Predose at Cycle 6 Day 1 (duration of each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Very Good Partial Response or better rate (VGPR)
Description
Very Good Partial Response or better rate defined as the proportion of participants with stringent complete response (sCR), complete response (CR) and very good partial response (VGPR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC).
Time Frame
Up to approximately 2 years
Title
Observed concentration before dosing (Ctrough)
Description
Observed Isatuximab plasma concentration
Time Frame
At 4 weeks i.e., predose at Cycle 2 Day 1 (duration of each cycle is 28 days)
Title
Incidence rate of infusion-reactions
Description
Proportion of participants with infusion-reactions related events
Time Frame
Up to approximately 4 years
Title
Percentage of participants satisfied or very satisfied with the injection method used to administer study medication
Description
Participant's satisfaction with isatuximab subcutaneous (SC) and intravenous (IV) will be assessed based on the Patient Experience and Satisfaction Questionnaires (PESQ) questionnaire.
Time Frame
At Cycle 5 Day 15
Title
Duration of response (DOR)
Description
DOR, defined as the time from the date of the first confirmed response to the date of first occurrence of progressive disease (PD) as determined by IRC or death, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better). In the absence of PD or death before the analysis cut-off date, the DOR will be censored at the date of the last valid disease assessment performed prior to initiation of a further anti-myeloma treatment or the analysis cut-off date, whichever is earlier. Participants with two or more consecutive missed assessments prior to PD or death will be censored at the last valid disease assessment.
Time Frame
Up to approximately 2 years
Title
Time to first response (TT1R)
Description
TT1R, defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. Same censoring rule applies as in the DOR endpoint.
Time Frame
Up to approximately 2 years
Title
Time to best response (TTBR)
Description
TTBR, defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that is subsequently confirmed. Same censoring rule applies as in the DOR endpoint
Time Frame
Up to approximately 2 years
Title
Progression free survival (PFS)
Description
PFS, defined as the time from the date of randomization to the date of first documentation of progressive disease as determined by IRC or the date of death from any cause, whichever comes first. Responses will be determined according to IMWG criteria. Progression based on paraprotein will be confirmed based on two consecutive assessments. PFS will be censored at the date of the last valid disease assessment not showing disease progression performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first. Participants with two or more consecutive missed assessments prior to PD or death will be censored at the last valid disease assessment.
Time Frame
Up to approximately 4 years
Title
Overall survival (OS)
Description
OS, defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date will be censored at the last date the participant was known to be alive or the cut-off date, whichever is first.
Time Frame
Up to approximately 4 years
Title
Progression free survival 2 (PFS2)
Description
PFS2, defined as time from the date of randomization to the date of first documentation of PD (as assessed by investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happens first. Same censoring rule applies as in the PFS endpoint.
Time Frame
Up to approximately 4 years
Title
Number of participants with treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs).
Description
Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the treatment period. The treatment period is defined as the time from first dose of study treatment up to 30 days after last dose of study treatment.
Time Frame
Up to approximately 4 years
Title
Pharmacokinetic (PK) parameter
Description
Maximum plasma concentration (Cmax)
Time Frame
Up to approximately 4 years
Title
PK parameter
Description
Area under the plasma concentration time curve over the dosing period (AUC)
Time Frame
Up to approximately 4 years
Title
Successful injection rate
Description
Number of successful injections with (investigational) isatuximab injector device divided by total number of actual injections
Time Frame
Up to approximately 4 years
Title
Percentage of participants with anti-drug antibodies (ADA) against isatuximab
Description
An ADA positive patient was defined as a subject either having treatment-induced ADA response (no positive ADA response at baseline and any positive response in the post baseline period, including the follow-up visit) or a treatment-boosted ADA response (a positive ADA response at baseline and a ≥4-fold increase in titer in the post baseline period including the follow-up visit).
Time Frame
Up to approximately 4 years
Title
Participant expectation questionnaire-baseline (PEQ-BL) score
Description
PEQ-BL is designed to assess the expectations of the participants regarding both the treatment (side effects, worth taking) and the administration method (confidence, comfortability, pain, side effects, potential time-savings), as well as to understand previous treatment experience from the participant (experience with injection methods for oncology medication).
Time Frame
Cycle 1 Day 1 ((duration of each cycle is 28 days)
Title
Patient experience and satisfaction questionnaire- follow up (PESQ-FU) score
Description
PESQ-FU, a 9-item questionnaire is designed to follow up on participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction).
Time Frame
Up to approximately 4 years
Title
Patient experience and satisfaction questionnaire-end of treatment (PESQ-EOT) score
Description
PESQ-EOT, a 17-item questionnaire is designed to assess participant experience and satisfaction regarding the treatment (side effects, worth taking and overall satisfaction) and the administration method (confidence, comfortability, pain, side effects, potential time-savings and overall satisfaction). This questionnaire includes also additional items to assess participant preference on injection method (subcutaneous or intravenous) and location of administration (at home or at clinic).
Time Frame
Up to approximately 4 years
Title
Change from baseline in the Health Resource Utilization and Productivity Questionnaire (HRUPQ) scores
Description
Medical resource utilization and participant productivity will be collected from participants through the HRUPQ questionnaire. The questions include number, nature (emergency or routine) and duration of hospitalizations; emergency room visits and outpatient medical encounters; and employment history. The HRUPQ contains 46 items.
Time Frame
Baseline; up to approximately 4 years
Title
Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score
Description
EORTC QLQ-C30 is a cancer-specific questionnaire that contains 30 items and provides a multidimensional assessment of Health Related Quality of Life (HRQL).
Time Frame
Baseline; up to approximately 4 years
Title
Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)
Description
EORTC QLQ-MY20, a 20-item questionnaire is used to assess symptoms and side effects due to the treatment or the disease which impact HRQL in participants with multiple myeloma.
Time Frame
Baseline; up to approximately 4 years
Title
Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores
Description
EQ-5D-5L questionnaire is a measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and visual analogue scale (VAS). The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the respondent's self-rated health on a 20 cm vertical, VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine.'
Time Frame
Baseline; up to approximately 4 years
Title
Number of participants with chromosomal abnormalities
Description
Explore chromosomal abnormalities (mainly but not limited to t(4;14), t(14;16), del(17p), and 1q21+)
Time Frame
Up to approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)) Exclusion Criteria: Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2 Primary refractory multiple myeloma participants Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or intolerant to anti-CD38 mAb agents Prior therapy with pomalidomide Participants with inadequate biological tests. Significant cardiac dysfunction Participants diagnosed or treated for another cancer within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy Concomitant plasma cell leukemia Active primary amyloid-light (AL) amyloidosis Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed. Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free for US & Canada)
Phone
800-633-1610
Ext
Option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HAL-Site Number:8400015
City
Prescott Valley
State/Province
Arizona
ZIP/Postal Code
86314
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic-Site Number:8400008
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Hattiesburg Clinic-Site Number:8400006
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Oncology Hematology, P.C.-Site Number:8400017
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health-Site Number:8400014
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology_Hematology Care Clinical Trials, LLC-Site Number:8400016
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Associates Of Oregon, P.C.-Site Number:8400018
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
George E. Wahlen Salt Lake City VA Medical Center-Site Number:8400011
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Individual Site Status
Recruiting
Facility Name
UW Cancer Center at ProHealth Care-Site Number:8400001
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320007
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320002
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320006
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320008
City
Caba
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
C1180
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320005
City
Caba
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
C1425ASG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Buenos Aires
ZIP/Postal Code
1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360007
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360004
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360003
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360008
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360009
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360006
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360001
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760003
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760002
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760001
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04537-081
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760004
City
Rio De Janeiro
ZIP/Postal Code
22775-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240001
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240004
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520005
City
Viña del Mar
State/Province
Valparaíso
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520004
City
Santiago
ZIP/Postal Code
8380455
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560022
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560010
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560006
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560002
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560020
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560019
City
Nanning
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560011
City
Qingdao
ZIP/Postal Code
266011
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560017
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560013
City
Shenyang
ZIP/Postal Code
110022
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560021
City
Shenzhen
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560007
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560009
City
Tianjin
ZIP/Postal Code
300032
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560018
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560003
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560008
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560004
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500006
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500002
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500005
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500004
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500001
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500007
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760005
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000002
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000005
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000003
City
Patra
ZIP/Postal Code
26500
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480002
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480004
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480003
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480008
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480005
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480006
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800001
City
Meldola
State/Province
Forlì-Cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800004
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800002
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800005
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800003
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920007
City
Kamogawa-shi
State/Province
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920005
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920012
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0072
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
603-8151
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Natori-shi
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920011
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920009
City
Yamagata-shi
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5780001
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160004
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160005
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Lublin
ZIP/Postal Code
20,081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Badalona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240007
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240005
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240006
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7520001
City
Borås
ZIP/Postal Code
50182
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580002
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260005
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260001
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
https://www.sanofistudies.com/S2PX/
Description
EFC15951 Relapsed/Refractory Multiple Myeloma USA website

Learn more about this trial

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

We'll reach out to this number within 24 hrs