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JOURNAL ONKOLOGIE – STUDIE
MagnetisMM-6

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

Rekrutierend

NCT-Nummer:
NCT05623020

Studienbeginn:
November 2022

Letztes Update:
16.04.2024

Wirkstoff:
Elranatamab, Daratumumab, Lenalidomide, Dexamethasone

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Pfizer

Collaborator:
-

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen

Studienlocations
(3 von 73)

Universitaetsklinikum Tuebingen
72076 Tübingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Darmkrebszentrum Klinikum Chemnitz
Flemmingstraße 2
9116 Chemnitz
DeutschlandRekrutierend» Google-Maps
St Vincent's Hospital Melbourne
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Epworth Hospital
3121 Richmond
AustraliaNoch nicht rekrutierend» Google-Maps
QEII Health Sciences Centre
B3H 2Y9 Halifax
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Fakultní nemocnice Brno Bohunice
625 00 Brno
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Olomouc
779 00 Olomouc
CzechiaNoch nicht rekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
12808 Praha 2
CzechiaRekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
31100 Toulouse
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Poitiers
86021 Poitiers
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
44093 Cedex 1 Nantes
FranceRekrutierend» Google-Maps
Evangelismos General Hospital of Athens
106 76 Athens
GreeceRekrutierend» Google-Maps
Alexandra General Hospital of Athens
115 28 Athens
GreeceRekrutierend» Google-Maps
University Hospital of Ioannina
455 00 Ioannina
GreeceNoch nicht rekrutierend» Google-Maps
Soroka Medical Center
8410101 Be'er Sheva
IsraelNoch nicht rekrutierend» Google-Maps
Rabin Medical Center
4910021 Petah-Tikva
IsraelNoch nicht rekrutierend» Google-Maps
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
5265601 Ramat Gan
IsraelNoch nicht rekrutierend» Google-Maps
Sourasky Medical Center
6423906 Tel Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Hadassah Medical Center
9112001 Jerusalem
IsraelNoch nicht rekrutierend» Google-Maps
Ospedale Santa Maria delle Croci
48121 Ravenna
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Casa Sollievo della Sofferenza
71013 San Giovanni Rotondo
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Casa Sollievo della Sofferenza
71013 San Giovanni Rotondo
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS San Gerardo dei Tintori
20900 Monza
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
10126 Torino
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Policlinico Paolo Giaccone
90127 Palermo
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Europeo di Oncologia IRCCS
20141 Milano
ItalyRekrutierend» Google-Maps
ASL PESCARA-Presidio Ospedaliero Pescara
65124 Pescara
ItalyRekrutierend» Google-Maps
AOU Policlinico Umberto I
00161 Roma
ItalyNoch nicht rekrutierend» Google-Maps
University of Fukui Hospital
910-1193 Eiheiji-cho,Yoshida-gun
JapanNoch nicht rekrutierend» Google-Maps
University of Fukui Hospital
910-1193 Yoshida-gun
JapanNoch nicht rekrutierend» Google-Maps
Gunma University Hospital
371-8511 Maebashi
JapanNoch nicht rekrutierend» Google-Maps
Iwate Medical University Hospital
028-3695 Shiwa-gun Yahaba-cho
JapanRekrutierend» Google-Maps
Iwate Medical University Hospital
028-3695 Yahaba-cho, Shiwa-gun
JapanRekrutierend» Google-Maps
Tohoku University Hospital
980-8574 Sendai-shi
JapanRekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Nagaizumi-cho,Sunto-gun
JapanRekrutierend» Google-Maps
Japanese Red Cross Medical Center
150-8935 Shibuya-ku
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Okayama Medical Center
701-1154 Okayama
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Okayama Medical Center
701-1192 Okayama
JapanNoch nicht rekrutierend» Google-Maps
Osaka Metropolitan University Hospital
545-0051 Osaka
JapanNoch nicht rekrutierend» Google-Maps
Osaka Metropolitan University Hospital
545-8586 Osaka
JapanNoch nicht rekrutierend» Google-Maps
Yamagata University Hospital
990-9585 Yamagata
JapanRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Namdong-gu
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun-gun
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
50-367 Wroclaw
PolandAktiv, nicht rekrutierend» Google-Maps
MTZ Clinical Research Powered by Pratia
02-127 Warszawa
PolandNoch nicht rekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne
80-214 Gdańsk
PolandAktiv, nicht rekrutierend» Google-Maps
Centrum Medyczne Pratia Poznań
60-185 Skorzewo
PolandRekrutierend» Google-Maps
Pratia Onkologia Katowice
40-519 Katowice
PolandAktiv, nicht rekrutierend» Google-Maps
Institut Català d'Oncologia (ICO) - Badalona
08916 Badalona
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia - L'Hospitalet
08908 L'Hospitalet Del Llobregat
SpainRekrutierend» Google-Maps
Hospital Clínic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia (ICO) - Girona
17007 Girona
SpainNoch nicht rekrutierend» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario Doctor Peset
46017 Valencia
SpainRekrutierend» Google-Maps
Hospital San Pedro de Alcántara
10003 Cáceres
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Fundación Jiménez Díaz
28040 Madrid
SpainNoch nicht rekrutierend» Google-Maps
China Medical University Hospital
404332 Taichung
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation-Linkou Branch
333 Taoyuan
TaiwanNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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)

2. Part 2: Progression free survival by blinded independent central review (Time Frame - From randomization up to 73 months.)

3. Part 2: Sustained minimal residual disease negativity rate (Time Frame - For at least 12 months after date of initial MRD-negative status)

Secondary outcome:

1. Overall Survival (Time Frame - From date of randomization up to 73 months)

2. Overall minimal residual disease negativity rate (Time Frame - From date of randomization up to 73 months)

3. Duration of minimal residual disease negativity (Part 2) (Time Frame - From date of minimal residual disease negative status up to 73 months)

4. PFS by investigator (Time Frame - From date of randomization up to 73 months)

5. PFS2 by investigator (Part 2) (Time Frame - From the date of randomization up to 73 months)

6. Objective Response Rate (Time Frame - From the date of randomization up to 73 months)

7. Complete Response Rate (Time Frame - From the date of randomization up to 73 months)

8. Time to Response (Time Frame - From the date of randomization to date of confirmed objective response up to 73 months)

9. Duration of Response (Time Frame - From the date of confirmed objective response up to 73 months)

10. Duration of Complete Response (Time Frame - From the date of confirmed complete response up to 73 months)

11. Frequency of treatment-emergent adverse events (Time Frame - From the date of first dose of study intervention up to 73 months)

12. Frequency of abnormal laboratory results (Time Frame - From the date of first dose of study intervention up to 73 months)

13. Elranatamab pharmacokinetics by pre-dose concentrations when used with lenalidomide and daratumumab (Time Frame - From date of first dose of study intervention up to 73 months):
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

14. Elranatamab pharmacokinetics by post-dose concentrations when used with lenalidomide and daratumumab (Time Frame - From date of first dose of study intervention up to 73 months):
Pharmacokinetics of elranatamab (post-dose serum concentrations of elranatamab)

15. Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab (Time Frame - From date of first dose of study intervention up to 73 months):
Immunogenicity of elranatamab

16. Titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab (Time Frame - From date of first dose of study intervention up to 73 months):
Immunogenicity of elranatamab

17. Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20 (Time Frame - From date the informed consent is signed up to 73 months):
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

18. Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Time Frame - From date the informed consent is signed up to 73 months):
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.

19. Part 1: Daratumumab and lenalidomide pharmacokinetics by pre-dose concentrations in combination with elranatamab (Time Frame - From date of first dose of study intervention up to 73 months):
Pharmacokinetics of daratumumab and lenalidomide (trough concentrations of daratumumab and lenalidomide)

Studien-Arme

  • Experimental: Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
  • Experimental: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
  • Experimental: Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
  • Active Comparator: Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone

Geprüfte Regime

  • Elranatamab:
    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
  • Daratumumab:
    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
  • Lenalidomide:
    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
  • Dexamethasone:
    Randomized

Quelle: ClinicalTrials.gov


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"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"

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