search
Back to results

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant (MagnetisMM-6)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elranatamab
Daratumumab
Lenalidomide
Dexamethasone
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Elranatamab, PF-06863135, B-Cell Maturation Antigen, Daratumumab, Lenalidomide, Multiple myeloma, MagnetisMM-6

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014) Measurable disease based on IMWG criteria as defined by at least 1 of the following: Serum M-protein ≥0.5 g/dL; Urinary M-protein excretion ≥200 mg/24 hours; Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant. Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant ECOG performance status ≤2. Not pregnant and willing to use contraception For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. Exclusion Criteria: Smoldering Multiple Myeloma. Monoclonal gammopathy of undetermined significance. Waldenströms Macroglobulinemia Plasma cell leukemia. Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator. For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD. For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention). Live attenuated vaccine administered within 4 weeks of the first dose of study intervention. Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.

Sites / Locations

  • Pindara Private HospitalRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Epworth FreemasonsRecruiting
  • The Alfred HospitalRecruiting
  • Epworth Hospital
  • QEII Health Sciences CentreRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Fakultní nemocnice Brno BohuniceRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice OlomoucRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
  • Evangelismos General Hospital of AthensRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • Hadassah Medical Center
  • Fondazione IRCCS San Gerardo dei Tintori
  • A.O.U. Policlinico Paolo Giaccone
  • Istituto Europeo di Oncologia IRCCS
  • University of Fukui Hospital
  • Gunma University Hospital
  • Iwate Medical University Hospital
  • Iwate Medical University Hospital
  • Shizuoka Cancer CenterRecruiting
  • Kyushu University Hospital
  • National Hospital Organization Okayama Medical Center
  • Osaka Metropolitan University Hospital
  • Yamagata University HospitalRecruiting
  • Gachon University Gil Medical Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • MTZ Clinical Research Powered by Pratia
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Medyczne Pratia PoznańRecruiting
  • Pratia Onkologia Katowice
  • Institut Català d'Oncologia (ICO) - BadalonaRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario Doctor PesetRecruiting
  • Hospital La PrincesaRecruiting
  • China Medical University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Chang Gung Medical Foundation-Linkou Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide

Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide

Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide

Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Part 1 Dose Limiting Toxicity
Part 2: Progression free survival by blinded independent central review
Part 2: Sustained minimal residual disease negativity rate

Secondary Outcome Measures

Overall Survival
Overall minimal residual disease negativity rate
Duration of minimal residual disease negativity (Part 2)
PFS by investigator
PFS2 by investigator (Part 2)
Objective Response Rate
Complete Response Rate
Time to Response
Duration of Response
Duration of Complete Response
Frequency of treatment-emergent adverse events
Frequency of abnormal laboratory results
Elranatamab pharmacokinetics by pre-dose concentrations when used with lenalidomide and daratumumab
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Elranatamab pharmacokinetics by post-dose concentrations when used with lenalidomide and daratumumab
Pharmacokinetics of elranatamab (post-dose serum concentrations of elranatamab)
Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
Titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the symptom scales/items represent a greater presence of symptoms.
Part 1: Daratumumab and lenalidomide pharmacokinetics by pre-dose concentrations in combination with elranatamab
Pharmacokinetics of daratumumab and lenalidomide (trough concentrations of daratumumab and lenalidomide)

Full Information

First Posted
October 26, 2022
Last Updated
October 11, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05623020
Brief Title
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Acronym
MagnetisMM-6
Official Title
MAGNETISMM-6: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
March 31, 2028 (Anticipated)
Study Completion Date
November 29, 2031 (Anticipated)

3. Sponsor/Collaborators

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

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
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab when administered in combination with daratumumab and lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Elranatamab, PF-06863135, B-Cell Maturation Antigen, Daratumumab, Lenalidomide, Multiple myeloma, MagnetisMM-6

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
Arm Type
Experimental
Arm Title
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
Arm Type
Experimental
Arm Title
Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
Arm Type
Experimental
Arm Title
Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Intervention Description
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Randomized
Primary Outcome Measure Information:
Title
Part 1 Dose Limiting Toxicity
Time Frame
From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab 76 with daratumumab and lenalidomide
Title
Part 2: Progression free survival by blinded independent central review
Time Frame
From randomization up to 73 months.
Title
Part 2: Sustained minimal residual disease negativity rate
Time Frame
For at least 12 months after date of initial MRD-negative status
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From date of randomization up to 73 months
Title
Overall minimal residual disease negativity rate
Time Frame
From date of randomization up to 73 months
Title
Duration of minimal residual disease negativity (Part 2)
Time Frame
From date of minimal residual disease negative status up to 73 months
Title
PFS by investigator
Time Frame
From date of randomization up to 73 months
Title
PFS2 by investigator (Part 2)
Time Frame
From the date of randomization up to 73 months
Title
Objective Response Rate
Time Frame
From the date of randomization up to 73 months
Title
Complete Response Rate
Time Frame
From the date of randomization up to 73 months
Title
Time to Response
Time Frame
From the date of randomization to date of confirmed objective response up to 73 months
Title
Duration of Response
Time Frame
From the date of confirmed objective response up to 73 months
Title
Duration of Complete Response
Time Frame
From the date of confirmed complete response up to 73 months
Title
Frequency of treatment-emergent adverse events
Time Frame
From the date of first dose of study intervention up to 73 months
Title
Frequency of abnormal laboratory results
Time Frame
From the date of first dose of study intervention up to 73 months
Title
Elranatamab pharmacokinetics by pre-dose concentrations when used with lenalidomide and daratumumab
Description
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Time Frame
From date of first dose of study intervention up to 73 months
Title
Elranatamab pharmacokinetics by post-dose concentrations when used with lenalidomide and daratumumab
Description
Pharmacokinetics of elranatamab (post-dose serum concentrations of elranatamab)
Time Frame
From date of first dose of study intervention up to 73 months
Title
Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Description
Immunogenicity of elranatamab
Time Frame
From date of first dose of study intervention up to 73 months
Title
Titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Description
Immunogenicity of elranatamab
Time Frame
From date of first dose of study intervention up to 73 months
Title
Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20
Description
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
Time Frame
From date the informed consent is signed up to 73 months
Title
Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
Description
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the symptom scales/items represent a greater presence of symptoms.
Time Frame
From date the informed consent is signed up to 73 months
Title
Part 1: Daratumumab and lenalidomide pharmacokinetics by pre-dose concentrations in combination with elranatamab
Description
Pharmacokinetics of daratumumab and lenalidomide (trough concentrations of daratumumab and lenalidomide)
Time Frame
From date of first dose of study intervention up to 73 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014) Measurable disease based on IMWG criteria as defined by at least 1 of the following: Serum M-protein ≥0.5 g/dL; Urinary M-protein excretion ≥200 mg/24 hours; Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant. Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant ECOG performance status ≤2. Not pregnant and willing to use contraception For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. Exclusion Criteria: Smoldering Multiple Myeloma. Monoclonal gammopathy of undetermined significance. Waldenströms Macroglobulinemia Plasma cell leukemia. Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator. For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD. For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention). Live attenuated vaccine administered within 4 weeks of the first dose of study intervention. Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Freemasons
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Hospital
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice Brno Bohunice
City
Brno
State/Province
Brno-město
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
State/Province
Moravskoslezský KRAJ
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
City
Toulouse
State/Province
Haute-garonne
ZIP/Postal Code
31100
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093 Cedex 1
Country
France
Individual Site Status
Recruiting
Facility Name
Evangelismos General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. Policlinico Paolo Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
University of Fukui Hospital
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun Yahaba-cho
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Iwate Medical University Hospital
City
Yahaba-cho, Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Shizuoka Cancer Center
City
Nagaizumi-cho,Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1154
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-0051
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Namdong-gu
State/Province
Incheon-gwangyeoksi [incheon]
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-127
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne Pratia Poznań
City
Skorzewo
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Institut Català d'Oncologia (ICO) - Badalona
City
Badalona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
State/Province
València
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071006
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

We'll reach out to this number within 24 hrs