MagnetisMM-7: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05317416

Collaborator

(none)

366

Enrollment

Locations

Arms

62.7

Anticipated Duration (Months)

3.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma who are MRD-positive after undergoing autologous stem cell transplant.

Participants in the study will either receive elrantamab as an injection under the skin at the study clinic or lenalidomide orally once daily at home. Participants who will receive elranatamab will start receiving one dose every week after the initial step-up doses. After 6 months of treatment, the frequency of clinic visits for injections will decrease to every other week. Participation in the study will be approximately five years.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Elranatamab Drug: Lenalidomide	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, 2-Arm, Phase 3 Study of Elranatamab (PF-06863135) Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease-Positive After Undergoing Autologous Stem-Cell Transplantation

Actual Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Jun 14, 2027

Anticipated Study Completion Date :

Jun 14, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Elranatamab	Drug: Elranatamab BCMA-CD3 bispecific antibody
Active Comparator: Arm B Lenalidomide	Drug: Lenalidomide Immunomodulatory drug

Arm

Intervention/Treatment

Experimental: Arm A

Elranatamab

Drug: Elranatamab

BCMA-CD3 bispecific antibody

Active Comparator: Arm B

Lenalidomide

Drug: Lenalidomide

Immunomodulatory drug

Outcome Measures

Primary Outcome Measures

Minimal Residual Disease negativity rate [12 months after randomization]
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Progression Free Survival [Assessed for up to approximately 5 years]
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Secondary Outcome Measures

Progression Free Survival [Assessed for up to approximately 5 years]
Progression Free Survival by investigator per IMWG response criteria
Overall minimal residual disease negativity rate [Assessed for up to approximately 5 years]
Minimal residual disease negativity rate per IMWG criteria
Duration of minimal residual disease negativity [Assessed for up to approximately 5 years]
Minimal residual disease negativity per IMWG criteria
Sustained minimal residual disease negativity rate [Assessed for up to approximately 5 years]
Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
Complete response rate [Assessed for up to approximately 5 years]
Complete response rate by blinded independent central review and by investigator per IMWG criteria
Duration of complete response [Assessed for up to approximately 5 years]
Duration of complete response by blinded independent central review and by investigator per IMWG criteria
Overall survival [For approximately 5 years]
Frequency of adverse events [Up to 90 days after last dose]
Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention
Frequency of laboratory abnormalities [Assessed for up to approximately 5 years]
Pre-dose concentrations of elranatamab [Assessed for up to approximately 5 years]
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Post-dose concentrations of elranatamab [Assessed for up to approximately 5 years]
Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [Assessed for up to approximately 5 years]
Immunogenicity of elranatamab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [Assessed for up to approximately 5 years]
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 symptom scales/items represent a greater presence of symptoms
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [Assessed for up to approximately 5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 6 months from ASCT.
Partial Response or better according to IMWG criteria at the time of randomization
MRD positive (≥10^-5) at screening by central laboratory NGS test (ClonoSEQ assay) Must have an archival bone marrow aspirate sample(s) that identified the dominant malignant (index) clone that is used to track MRD status. This sample sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
ECOG performance status ≤1
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
Not pregnant and willing to use contraception

Exclusion Criteria:

Plasma cell leukemia
POEMS syndrome
Systemic amyloid light chain amyloidosis
Previous MM maintenance treatment
Prior treatment with BCMA targeted therapy
Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
2	Epworth Healthcare	East Melbourne	Victoria	Australia	3002
3	Slade Pharmacy	Richmond		Australia	3121
4	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site God	Yvoir	Namur	Belgium	5530
5	Hamilton Health Sciences Corporation	Hamilton	Ontario	Canada	L8L 8E7
6	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
7	Oulun yliopistollinen sairaala	Oulu	Pohjois-pohjanmaa	Finland	90220
8	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)	Helsinki	Uusimaa	Finland	00029
9	Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE	Toulouse	Haute-garonne	France	31100
10	Hopital Claude Huriez - CHU de Lille	Lille	Nord	France	59000
11	Hopital Lyon Sud	Pierre Benite		France	69495
12	Hôpital Saint Antoine	Paris	Île-de-france	France	75571
13	Universitätsklinikum Würzburg	Würzburg	Bayern	Germany	97080
14	Klinikum Chemnitz gGMbH	Chemnitz		Germany	09116
15	Alexandra General Hospital of Athens	Athens	Attikí	Greece	115 28
16	Theageneio Cancer Hospital of Thessaloniki	Thessaloniki	Kentrikí Makedonía	Greece	546 39
17	Evangelismos Hospital	Athens		Greece	10676
18	University Hospital of Ioannina	Ioannina	Ípeiros	Greece	455 00
19	Dél-Pesti Centrumkórház	Budapest		Hungary	1097
20	Medanta-The Medicity	Gurugram	Haryana	India	122001
21	Fortis Memorial Research Institute	Gurugram	Haryana	India	122002
22	Artemis hospital	Gurugram	Haryana	India	122003
23	Tata Medical Center	Kolkata	WEST Bengal	India	700160
24	Rajiv Gandhi Cancer Institute And Research Centre	Delhi		India	110085
25	Sheba Medical Center	Ramat Gan	Hamerkaz	Israel	5262100
26	Sourasky Medical Center	Tel Aviv	Tell Abīb	Israel	6423906
27	Hadassah Medical Center	Jerusalem	Yerushalayim	Israel	9112001
28	Shaare Zedek Medical Center	Jerusalem		Israel	9103102
29	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio	Italy	00168
30	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia	Italy	20122
31	Ospedale Le Scotte	Siena	Toscana	Italy	53100
32	Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte	Siena	Toscana	Italy	53100
33	IRCCS - AOU di Bologna	Bologna		Italy	40138
34	Nagoya City University Hospital	Nagoya	Aichi	Japan	467-8602
35	Gunma University Hospital	Maebashi	Gunma	Japan	371-8511
36	Iwate Medical University Hospital	Yahaba-cho, Shiwa-gun	Iwate	Japan	028-3695
37	University Hospital,Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto	Japan	602-8566
38	Tohoku University Hospital	Sendai	Miyagi	Japan	980-8574
39	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka	Japan	431-3192
40	Hamamatsu University Hospital	Hamamatsu	Shizuoka	Japan	431-3192
41	Shizuoka Cancer Center	Nagaizumi	Shizuoka	Japan	411-8777
42	Shizuoka Cancer Center	Sunto-gun	Shizuoka	Japan	411-8777
43	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo	Japan	150-8935
44	National Hospital Organization Kumamoto Medical Center	Kumamoto		Japan	860-0008
45	University Hospital,Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
46	National Hospital Organization Okayama Medical Center	Okayama		Japan	701-1192
47	Osaka Metropolitan University Hospital	Osaka		Japan	545-8586
48	Japanese Red Cross Medical Center	Tokyo		Japan	150-8935
49	Yamagata University Hospital	Yamagata		Japan	990-9585
50	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [incheon]	Korea, Republic of	21565
51	Chonnam National University Hwasun Hospital	Hwasun Gun	Jeonranamdo	Korea, Republic of	58128
52	Seoul National University Bundang Hospital	Seongnam	Kyǒnggi-do	Korea, Republic of	13620
53	Pusan National University Hospital	Busan	Pusan-kwangyǒkshi	Korea, Republic of	49241
54	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [seoul]	Korea, Republic of	03080
55	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]	Korea, Republic of	06351
56	The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)	Seoul	Seoul-teukbyeolsi [seoul]	Korea, Republic of	06591
57	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [seoul]	Korea, Republic of	06591
58	Kyungpook National University	Daegu	Taegu-kwangyǒkshi	Korea, Republic of	41944
59	Kyungpook National University Hospital	Jung-gu	Taegu-kwangyǒkshi	Korea, Republic of	41944
60	HagaZiekenhuis	Den Haag	Zuid-holland	Netherlands	2545 AA
61	Centrum Medyczne Pratia Poznań	Skorzewo	Wielkopolskie	Poland	60-185
62	Uniwersyteckie Centrum Kliniczne,	Gdansk		Poland	80-214
63	Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku	Wroclaw		Poland	50-367
64	Pratia Onkologia Katowice	Katowice	Śląskie	Poland	40-519
65	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [barcelona]	Spain	08035
66	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet Del Llobregat	Barcelona [barcelona]	Spain	08908
67	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona [barcelona]	Spain	08221
68	Institut Catala d' Oncologia. Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
69	Hospital Universitario Mutua Terrassa	Terrassa	Barcelona	Spain	08221
70	Hospital Universitario de Salamanca	Salamanca	Castilla Y LEÓN	Spain	37007
71	Hospital Clínic de Barcelona	Barcelona	Catalunya [cataluña]	Spain	08036
72	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid	Spain	28223
73	Clinica Universidad de Navarra	Pamplona	Navarra	Spain	31008
74	Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta	Gerona		Spain	17007
75	Hospital La Princesa	Madrid		Spain	28006
76	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007
77	Hospital Universitario HM Sanchinarro	Madrid		Spain	28050
78	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca		Spain	37007
79	Hospital Universitari i Politecnic La Fe	València		Spain	46026
80	China Medical University Hospital	Taichung		Taiwan	40447
81	Taichung Veterans General Hospital	Taichung		Taiwan	407
82	National Taiwan University Hospital	Taipei		Taiwan	10002
83	Taipei Veterans General Hospital	Taipei		Taiwan	11217
84	Chang Gung Medical Foundation-Linkou Branch	Taoyuan		Taiwan	333
85	Medipol Mega Universite Hastanesi	İstanbul	İ̇stanbul	Turkey	34214
86	Sisli Florence Nightingale Hastanesi	İstanbul	İ̇stanbul	Turkey	34381
87	Ege Universitesi Hastanesi	Izmir	İ̇zmir	Turkey	35100
88	Dokuz Eylul Universitesi Hastanesi	İzmir	İ̇zmir	Turkey	35340
89	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara		Turkey	06100
90	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi	Ankara		Turkey	06200
91	Gazi Universitesi	Ankara		Turkey	06560
92	Akdeniz Universitesi Hastanesi	Antalya		Turkey	07070
93	Aydın Adnan Menderes Universitesi Hastanesi	Aydin		Turkey	09100
94	Erciyes Universitesi Tıp Fakultesi Hastaneleri	Kayseri		Turkey	38030
95	Özel Anadolu Sağlık Merkezi	Kocaeli		Turkey	41400