Trial Title:
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
NCT ID:
NCT05623020
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Daratumumab
Conditions: Keywords:
Elranatamab
PF-06863135
B-Cell Maturation Antigen
Daratumumab
Lenalidomide
Multiple myeloma
MagnetisMM-6
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elranatamab
Description:
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Arm group label:
Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 1: Elranatamab + Lenalidomide
Arm group label:
Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 2: Randomized Arm A: Elranatamab + Lenalidomide
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Arm group label:
Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Arm group label:
Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 1: Elranatamab + Lenalidomide
Arm group label:
Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
Arm group label:
Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
Arm group label:
Part 2: Randomized Arm A: Elranatamab + Lenalidomide
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Randomized
Arm group label:
Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
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 or Elranatamab 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 in combination with daratumumab and lenalidomide or in combination with
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 or elranatamab and lenalidomide compared with the combination of
daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed
transplant-ineligible multiple myeloma.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Epworth Freemasons
Address:
City:
Melbourne
Zip:
3002
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Epworth Hospital
Address:
City:
Richmond
Zip:
3121
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
QEII Health Sciences Centre
Address:
City:
Halifax
Zip:
B3H 2Y9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Fakultní nemocnice Brno Bohunice
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Ostrava
Address:
City:
Ostrava
Zip:
708 52
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Olomouc
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Fakultni nemocnice Olomouc
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Vseobecna fakultni nemocnice v Praze
Address:
City:
Praha 2
Zip:
12808
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Address:
City:
Toulouse
Zip:
31100
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Poitiers
Address:
City:
Poitiers
Zip:
86021
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Address:
City:
Nantes
Zip:
44093 Cedex 1
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Tuebingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Klinikum Chemnitz
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Evangelismos General Hospital of Athens
Address:
City:
Athens
Zip:
106 76
Country:
Greece
Status:
Recruiting
Facility:
Name:
Alexandra General Hospital of Athens
Address:
City:
Athens
Zip:
115 28
Country:
Greece
Status:
Recruiting
Facility:
Name:
University Hospital of Ioannina
Address:
City:
Ioannina
Zip:
455 00
Country:
Greece
Status:
Not yet recruiting
Facility:
Name:
Soroka Medical Center
Address:
City:
Be'er Sheva
Zip:
8410101
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah-Tikva
Zip:
4910021
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
AUSL di Piacenza
Address:
City:
Piacenza
Zip:
29121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Maria delle Croci
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Zip:
71013
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
IRCCS Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Zip:
71013
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
A.O.U. Policlinico Paolo Giaccone
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Istituto Europeo di Oncologia IRCCS
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASL PESCARA-Presidio Ospedaliero Pescara
Address:
City:
Pescara
Zip:
65124
Country:
Italy
Status:
Recruiting
Facility:
Name:
AOU Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
University of Fukui Hospital
Address:
City:
Eiheiji-cho,Yoshida-gun
Zip:
910-1193
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
University of Fukui Hospital
Address:
City:
Yoshida-gun
Zip:
910-1193
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Gunma University Hospital
Address:
City:
Maebashi
Zip:
371-8511
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Iwate Medical University Hospital
Address:
City:
Shiwa-gun Yahaba-cho
Zip:
028-3695
Country:
Japan
Status:
Recruiting
Facility:
Name:
Iwate Medical University Hospital
Address:
City:
Yahaba-cho, Shiwa-gun
Zip:
028-3695
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai-shi
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Nagaizumi-cho,Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
Japanese Red Cross Medical Center
Address:
City:
Shibuya-ku
Zip:
150-8935
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Okayama Medical Center
Address:
City:
Okayama
Zip:
701-1154
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
National Hospital Organization Okayama Medical Center
Address:
City:
Okayama
Zip:
701-1192
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Osaka Metropolitan University Hospital
Address:
City:
Osaka
Zip:
545-0051
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Osaka Metropolitan University Hospital
Address:
City:
Osaka
Zip:
545-8586
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Namdong-gu
Zip:
21565
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun-gun
Zip:
58128
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Address:
City:
Dordrecht
Zip:
3318 AT
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Address:
City:
Wroclaw
Zip:
50-367
Country:
Poland
Status:
Active, not recruiting
Facility:
Name:
MTZ Clinical Research Powered by Pratia
Address:
City:
Warszawa
Zip:
02-127
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Active, not recruiting
Facility:
Name:
Centrum Medyczne Pratia Poznań
Address:
City:
Skorzewo
Zip:
60-185
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Pratia Onkologia Katowice
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Active, not recruiting
Facility:
Name:
Institut Català d'Oncologia (ICO) - Badalona
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia - L'Hospitalet
Address:
City:
L'Hospitalet Del Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia (ICO) - Girona
Address:
City:
Girona
Zip:
17007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Doctor Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital San Pedro de Alcántara
Address:
City:
Cáceres
Zip:
10003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital La Princesa
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
404332
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Medical Foundation-Linkou Branch
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Not yet recruiting
Start date:
November 10, 2022
Completion date:
November 29, 2031
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05623020
https://pmiform.com/clinical-trial-info-request?StudyID=C1071006
