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A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Linvoseltamab
Daratumumab
Carfilzomib
Lenalidomide
Bortezomib
Pomalidomide
Isatuximab
Fianlimab
Cemiplimab
Nirogacestat
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed/Refractory Multiple Myeloma (RRMM), B-cell maturation antigen (BCMA), Anti-CD3 monoclonal antibodies (mAbs)

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  2. Relapsed/refractory multiple myeloma (MM): Progression of disease following at least 3 lines of therapy, or least 2 lines of therapy and either:

    • prior exposure to at least 1 anti-CD38 antibody, 1 IMiD and 1 PI or
    • double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD. Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated. However, patients cannot be refractory to an anti-CD38 antibody-containing regimen. In addition, patients must have a 6-month washout from prior anti-CD38 antibody therapy.

    Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose. However, patients cannot be refractory to a carfilzomib-containing regimen. In addition, patients must have a 6-month washout from prior carfilzomib therapy.

    Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose. However, a patient cannot be refractory to any combination regimen that included 25 mg of lenalidomide. In addition, patients must have a 6-month washout from prior lenalidomide therapy (including maintenance therapy).

    Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose. However, a patient cannot be refractory to any combination regimen including the approved induction dose of bortezomib. In addition, patients must have a 6-month washout from prior bortezomib therapy.

  3. Participants must have measurable disease and as defined in the protocol for response assessment as per the 2016 International Myeloma Working Group (IMWG) response assessment criteria
  4. Adequate creatinine clearance, hematologic and hepatic functions, as defined in protocol
  5. Life expectancy of at least 6 months

Key Exclusion Criteria:

  1. Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  2. Participants with known MM brain lesions or meningeal involvement
  3. Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter.
  4. History of allogeneic stem cell transplantation, or autologous stem cell transplantation within 12 weeks of the start of study drug regimen
  5. For participants with peripheral neuropathy grade ≥2 receiving bortezomib-based treatment (cohort 4 only)
  6. Prior treatment with BCMA-directed immunotherapies, including any chimeric antigen receptor T cell (CAR T) therapy (Note: BCMA antibody-drug conjugates are not excluded)
  7. History of neurodegenerative condition or central nervous system (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded
  8. Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential
  9. Cardiac ejection fraction <40% by echocardiogram (Echo) or multigated acquisition (MUGA) scan.
  10. Pregnant or breasting feeding women or women of childbearing potential (WOCBP) with positive pregnancy test result
  11. WOCBP or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

  • Ohio State UniversityRecruiting
  • Chu De LilleRecruiting
  • CHU de MontpellierRecruiting
  • AP-HP Hôpital Necker - Enfants MaladesRecruiting
  • CHU de PoitiersRecruiting
  • General Hospital of Athens Alexandra - Department of Clinical TherapeuticsRecruiting
  • General Hospital of Athens AlexandraRecruiting
  • Hospital Universitario Marqués de Valdecilla (HUMV)Recruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario Germans Trias i PujolRecruiting
  • Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de BarcelonaRecruiting
  • Hospital universitiario de La PrinceaRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Ramon Y CajalRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario Quiron Salud MadridRecruiting
  • Hospital Universitario de SalamancaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Linvoseltamab + Daratumumab

Cohort 2: Linvolseltamab + Carfilzomib

Cohort 3: Linvoseltamab + Lenalidomide

Cohort 4: Linvoseltamab + Bortezomib

Cohort 5: Linvoseltamab + Pomalidomide

Cohort 6: Linvoseltamab + Isatuximab

Cohort 7: Linvoseltamab + Fianlimab

Cohort 8: Linvoseltamab + Cemiplimab

Cohort 9: Linvoseltamab + Nirogacestat

Arm Description

Linvoseltamab + Daratumumab

Linvoseltamab + Carfilzomib

Linvoseltamab + Lenalidomide

Linvoseltamab + Bortezomib

Linvoseltamab + Pomalidomide

Linvoseltamab + Isatuximab

Linvoseltamab + Fianlimab

Linvoseltamab + Cemiplimab

Linvoseltamab + Nirogacestat

Outcomes

Primary Outcome Measures

Incidence of pre-defined safety criteria or dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Dose finding portion only
Incidence of treatment-emergent adverse events (TEAEs)
Severity of TEAEs
Incidence of serious adverse events (SAEs)
Severity of SAEs
Incidence of adverse events of special interest (AESIs)
Severity of AESIs
Incidence of laboratory abnormalities
≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]

Secondary Outcome Measures

Objective response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria
Duration of response (DOR) by IMWG criteria
Progression-free survival (PFS) as measured by IMWG criteria
Rate of minimal residual disease (MRD) negative status by IMWG criteria
Concentrations of total REGN5458 in serum over time
Incidence over time of anti-drug antibodies (ADAs) to REGN5458
Overall Survival (OS)

Full Information

First Posted
November 18, 2021
Last Updated
September 4, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05137054
Brief Title
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Official Title
Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
January 13, 2027 (Anticipated)
Study Completion Date
August 7, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

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
The study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after multiple prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma What side effects may happen from taking linvoseltamab together with another cancer treatment How much study drug is in your blood at different times Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed/Refractory Multiple Myeloma (RRMM), B-cell maturation antigen (BCMA), Anti-CD3 monoclonal antibodies (mAbs)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
317 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Linvoseltamab + Daratumumab
Arm Type
Experimental
Arm Description
Linvoseltamab + Daratumumab
Arm Title
Cohort 2: Linvolseltamab + Carfilzomib
Arm Type
Experimental
Arm Description
Linvoseltamab + Carfilzomib
Arm Title
Cohort 3: Linvoseltamab + Lenalidomide
Arm Type
Experimental
Arm Description
Linvoseltamab + Lenalidomide
Arm Title
Cohort 4: Linvoseltamab + Bortezomib
Arm Type
Experimental
Arm Description
Linvoseltamab + Bortezomib
Arm Title
Cohort 5: Linvoseltamab + Pomalidomide
Arm Type
Experimental
Arm Description
Linvoseltamab + Pomalidomide
Arm Title
Cohort 6: Linvoseltamab + Isatuximab
Arm Type
Experimental
Arm Description
Linvoseltamab + Isatuximab
Arm Title
Cohort 7: Linvoseltamab + Fianlimab
Arm Type
Experimental
Arm Description
Linvoseltamab + Fianlimab
Arm Title
Cohort 8: Linvoseltamab + Cemiplimab
Arm Type
Experimental
Arm Description
Linvoseltamab + Cemiplimab
Arm Title
Cohort 9: Linvoseltamab + Nirogacestat
Arm Type
Experimental
Arm Description
Linvoseltamab + Nirogacestat
Intervention Type
Drug
Intervention Name(s)
Linvoseltamab
Other Intervention Name(s)
REGN5458
Intervention Description
Linvoseltamab is administered by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Darzalex®; Darzalex Faspro™
Intervention Description
Daratumumab is administered by IV infusion and/or subcutaneous (SC) injection; SC injection may be used after a minimum of 2 cycles of IV administration at the investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
Kyprolis®
Intervention Description
Carfilzomib is administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid®
Intervention Description
Lenalidomide is administered by mouth (PO) as a capsule
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade®
Intervention Description
Bortezomib is administered by IV infusion or SC injection
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Imnovid, Pomalyst®
Intervention Description
Pomalidomide is administered by mouth (PO) as a capsule
Intervention Type
Drug
Intervention Name(s)
Isatuximab
Other Intervention Name(s)
Sarclisa®
Intervention Description
Isatuximab is administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
Fianlimab
Other Intervention Name(s)
REGN3767
Intervention Description
Fianlimab is administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
LIBTAYO
Intervention Description
Cemiplimab is administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
Nirogacestat
Other Intervention Name(s)
PF-03084014
Intervention Description
Nirogacestat is administered by mouth (PO) as a tablet
Primary Outcome Measure Information:
Title
Incidence of pre-defined safety criteria or dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Description
Dose finding portion only
Time Frame
Up to 28 Days
Title
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
Up to 5 Years
Title
Severity of TEAEs
Time Frame
Up to 5 Years
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 5 Years
Title
Severity of SAEs
Time Frame
Up to 5 Years
Title
Incidence of adverse events of special interest (AESIs)
Time Frame
Up to 5 Years
Title
Severity of AESIs
Time Frame
Up to 5 Years
Title
Incidence of laboratory abnormalities
Description
≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]
Time Frame
Up to 5 Years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria
Time Frame
Up to 5 Years
Title
Duration of response (DOR) by IMWG criteria
Time Frame
Up to 5 Years
Title
Progression-free survival (PFS) as measured by IMWG criteria
Time Frame
Up to 5 Years
Title
Rate of minimal residual disease (MRD) negative status by IMWG criteria
Time Frame
Up to 5 Years
Title
Concentrations of total REGN5458 in serum over time
Time Frame
Up to 5 Years
Title
Incidence over time of anti-drug antibodies (ADAs) to REGN5458
Time Frame
Up to 5 Years
Title
Overall Survival (OS)
Time Frame
Up to 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Key Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Participants must have measurable disease as defined in the protocol according to International Myeloma Working Group (IMWG) consensus criteria Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol Life expectancy of at least 6 months. Cohort Specific Inclusion Criteria: For the below cohorts, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 proteasome inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD. Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated. However, participants enrolled in the expansion portion cannot be refractory to an anti-CD38 antibody containing regimen. In addition, all participants must have at least a 6-month washout from prior anti-CD38 antibody therapy. Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose. Carfilzomib-refractory participants may enroll in the dose finding portion provided they are triple-class refractory (PI, IMiD, anti-CD38 antibody). However, participants enrolled in the dose expansion portion cannot be refractory to carfilzomib. In addition, all participants must have at least a 6-month washout from prior carfilzomib therapy. Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose. However, a participant cannot be refractory to any combination regimen that included 25 mg of lenalidomide. In addition, participants must have at least a 6-month washout from any prior lenalidomide therapy (including maintenance therapy). Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose. Bortezomib-refractory participants may enroll in the dose finding portion provided they are triple-class refractory (PI, IMiD, anti-CD38 antibody). However, participants enrolled in the dose expansion portion cannot be refractory to bortezomib. In addition, all participants must have at least a 6-month washout from prior bortezomib therapy. Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose. Additionally, participants must undergo at least a 6-month washout following prior pomalidomide therapy before enrollment. Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated. Additionally, participants must undergo at least a 3-month washout following prior anti-CD38 antibody therapy before enrollment. Cohort 7 and 8: RRMM with progressive disease and one of the following: Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1IMiD, and 1 PI or Triple-class refractory disease (anti-CD38 antibody, IMiD, PI) Cohort 9: each participant must have progressive RRMM and the following: Received at least 3 lines of therapy and Triple-class refractory disease (anti-CD38 antibody, IMiD, PI) General Key Exclusion Criteria: Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Participants with known MM brain lesions or meningeal involvement Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter History of allogeneic stem cell transplantation, or autologous stem cell transplantation within 12 weeks of the start of study drug regimen Unless stated otherwise in a specific sub-protocol, prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and bispecific T-cell engagers (BiTEs), and BCMA chimeric antigen receptor (CAR) T cells (Note: BCMA antibody-drug conjugates are not excluded) History of progressive multifocal leukoencephalopathy, neurodegenerative condition or central nervous system (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential Cardiac ejection fraction <40% by echocardiogram (Echo) or multigated acquisition (MUGA) scan. Cohort Specific Exclusion Criteria: Cohort 3: 1. Known malabsorption syndrome or pre-existing gastrointestinal (GI) conditions that may impair absorption of lenalidomide (eg, gastric bypass, lap band, or other gastric procedures that would alter absorption); delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed. Cohort 4: 1. Peripheral neuropathy grade ≥2 Cohort 5: 1. Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide (eg, gastric bypass, lap band, or other gastric procedures that would alter absorption); delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed. Cohort 7: Prior treatment with anti-lymphocyte activation gene 3 (LAG-3) agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-programmed cell death protein 1 (PD-1) antibodies is permitted, as described in the protocol. Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol. Prior solid organ transplant. History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies. Cohort 8: Prior treatment with anti-PD-1 or anti-PD-L1 agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibodies is permitted, as described in the protocol. Encephalitis or meningitis in the year prior to enrollment. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment. Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol. Prior solid organ transplant. History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies. Cohort 9: Abnormal quantity (QT) interval corrected by Fridericia's formula (QTcF), as described in the protocol Use of concomitant medications that are known to prolong the QT/QTcF interval including Class Ia and Class III antiarrhythmics at the time of informed consent Ongoing use or anticipated use of food or drugs that are known strong/moderate cytochrome P450 (CYP)3A4 inhibitors, or strong CYP3A inducers within 14 days prior to first dose of nirogacestat Known malabsorption syndrome or existing gastrointestinal GI conditions that may impair absorption of nirogacestat (eg, gastric bypass, lap band, or other gastric procedures that would alter absorption); delivery of nirogacestat via nasogastric tube or gastrostomy tube is not allowed. NOTE: Other protocol defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Chu De Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
340090
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Alexandra - Department of Clinical Therapeutics
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens Alexandra
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla (HUMV)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital universitiario de La Princea
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quiron Salud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

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