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A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (RedirecTT-1)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Talquetamab
Teclistamab
Daratumumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria based on documented medical history
  • Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy (except as noted in point 'a' and 'b'). (a) For cohorts without daratumumab, prior lines of therapy must include a proteasome inhibitor (PI) (example, bortezomib, carfilzomib, ixazomib), an immunomodulatory drug (IMiD) (example, thalidomide, lenalidomide, pomalidomide), and an anti-CD38 therapy (example, daratumumab, isatuximab) in any order. (b) For cohorts with daratumumab, prior lines of therapy must include a PI (example, bortezomib, carfilzomib, ixazomib) and an IMiD (example, thalidomide, lenalidomide, pomalidomide). Treatment with an anti-CD38 therapy (example, daratumumab) is allowed greater than equal to (>=) 90 days prior to study treatment if the participant did not discontinue prior treatment due to adverse events related to anti-CD38 therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration
  • Women of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 24 hours prior to the first step-up dose and the first dose of each treatment cycle
  • Men must agree not to donate sperm for reproduction during the study and for a minimum 100 days after receiving the last dose of study treatment

Exclusion Criteria:

  • Prior anticancer therapy as follows: a) targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; b) monoclonal antibody treatment for multiple myeloma within 21 days; c) cytotoxic therapy within 21 days; d) proteasome inhibitor (PI) therapy within 14 days; e) immunomodulatory drug (IMiD) therapy within 7 days; f) radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy; g) gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer [NK] cells) within 3 months
  • A cumulative dose of corticosteroids equivalent to more than or equal to (>=) 140 milligram (mg) of prednisone within 14 days
  • Live, attenuated vaccine within 4 weeks prior to first dose of study drug unless approved by sponsor
  • Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV RNA testing
  • Known allergies, hypersensitivity, or intolerance to daratumumab, talquetamab, teclistamab, or their excipients

Sites / Locations

  • Colorado Blood Cancer InstituteRecruiting
  • Washington University in St. LouisRecruiting
  • Mount Sinai Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Cleveland ClinicRecruiting
  • Alberta Health ServicesRecruiting
  • McGill University Health CentreRecruiting
  • Hadassah Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. Univ. Fund. Jimenez DiazRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Part 3: Phase 2

Arm Description

Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.

Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R[s]) of the study treatment identified in Part 1.

Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants with Dose Limiting Toxicity (DLT)
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.
Part 2: Number of Participants with Adverse Events and SAEs by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Part 3: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).

Secondary Outcome Measures

Parts 1, 2 and 3: Serum Concentration of Talquetamab
Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.
Parts 1, 2 and 3: Serum Concentration of Teclistamab
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.
Part 1 and Part 2: Serum Concentration of Daratumumab
Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab
Number of participants with anti-drug antibodies to talquetamab will be assessed.
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab
Number of participants with anti-drug antibodies to teclistamab will be assessed.
Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab
Number of participants with anti-drug antibodies to daratumumab will be assessed.
Part 1 and Part 2: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate
VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria.
Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate
CR or better response rate (sCR+CR) is defined as the percentage of participants who achieve a CR or better response according to the IMWG criteria.
Part 1 and Part 2: Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria.
Parts 1, 2 and 3: Duration of Response (DOR)
DOR will be calculated among responders (with PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
Parts 1, 2 and 3: Time to Response
Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Part 3: Progression free Survival (PFS)
PFS is defined as the time from the date of first dose to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Part 3: Overall Survival (OS)
OS is measured from the date of first dose to the date of the participant's death.
Part 3: Number of Participants with Adverse Events
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Part 3: Number of Participants with Adverse Events by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

Full Information

First Posted
October 12, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04586426
Brief Title
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Acronym
RedirecTT-1
Official Title
A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 27, 2025 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).
Detailed Description
Multiple myeloma is a malignant plasma cell disorder characterized by production of monoclonal proteins (M proteins), which are comprised of pathologic immunoglobulins (Ig) or fragments of such, which have subsequently lost their normal function. Rationale for combining talquetamab and teclistamab is the targeting of multiple proteins on the surface of multiple myeloma cells resulting in cell lysis. This study consists of 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT] visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s) for each participant). End of study is defined as 2 years after the last participant has received his or her initial dose of the treatment combination. Total duration of study is Approximately 5 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R[s]) of the study treatment identified in Part 1.
Arm Title
Part 3: Phase 2
Arm Type
Experimental
Arm Description
Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.
Intervention Type
Drug
Intervention Name(s)
Talquetamab
Other Intervention Name(s)
JNJ-64407564
Intervention Description
Talquetamab will be administered by subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Teclistamab will be administered by SC injection.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Daratumumab will be administered by SC injection.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants with Dose Limiting Toxicity (DLT)
Description
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Time Frame
Approximately 5 years
Title
Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Description
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Time Frame
Approximately 5 years
Title
Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Description
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.
Time Frame
Approximately 5 years
Title
Part 2: Number of Participants with Adverse Events and SAEs by Severity
Description
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Time Frame
Approximately 5 years
Title
Part 3: Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).
Time Frame
Approximately 5 years
Secondary Outcome Measure Information:
Title
Parts 1, 2 and 3: Serum Concentration of Talquetamab
Description
Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Serum Concentration of Teclistamab
Description
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.
Time Frame
Approximately 5 years
Title
Part 1 and Part 2: Serum Concentration of Daratumumab
Description
Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab
Description
Number of participants with anti-drug antibodies to talquetamab will be assessed.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab
Description
Number of participants with anti-drug antibodies to teclistamab will be assessed.
Time Frame
Approximately 5 years
Title
Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab
Description
Number of participants with anti-drug antibodies to daratumumab will be assessed.
Time Frame
Approximately 5 years
Title
Part 1 and Part 2: Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate
Description
VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate
Description
CR or better response rate (sCR+CR) is defined as the percentage of participants who achieve a CR or better response according to the IMWG criteria.
Time Frame
Approximately 5 years
Title
Part 1 and Part 2: Stringent Complete Response (sCR) Rate
Description
sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Duration of Response (DOR)
Description
DOR will be calculated among responders (with PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
Time Frame
Approximately 5 years
Title
Parts 1, 2 and 3: Time to Response
Description
Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Time Frame
Approximately 5 years
Title
Part 3: Progression free Survival (PFS)
Description
PFS is defined as the time from the date of first dose to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time Frame
Approximately 5 years
Title
Part 3: Overall Survival (OS)
Description
OS is measured from the date of first dose to the date of the participant's death.
Time Frame
Approximately 5 years
Title
Part 3: Number of Participants with Adverse Events
Description
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time Frame
Approximately 5 years
Title
Part 3: Number of Participants with Adverse Events by Severity
Description
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Time Frame
Approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration Exclusion Criteria: All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment. All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Alberta Health Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

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