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

NCT05623020 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: C1071006MAGNETISMM-62024-514139-50-00
• Study Type: interventional
• Target: 1,116
• Locations: 13 countries
• Sites: 39

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, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed 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 rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Elranatamab; PF-06863135; B-Cell Maturation Antigen; Daratumumab; Lenalidomide; Multiple myeloma; MagnetisMM-6; Bortezomib

Outcome Measures

Primary Outcomes (3)

• Part 1 Dose Limiting Toxicity

  From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide

• Part 2: Progression free survival per IMWG

  From randomization up to 97 months.

• Part 2: Minimal Residual Disease negative CR rate

  At 12 months after randomization

Secondary Outcomes (18)

• Overall Survival

  From date of randomization up to 97 months

• Overall minimal residual disease negative CR rate

  From date of randomization up to 97 months

• Sustained MRD negative CR rate (Part 2)

  From date of randomization up to 97 months

• Duration of minimal residual disease negative CR (Part 2)

  From date of minimal residual disease negative CR status up to 97 months

• PFS by investigator

  From date of randomization up to 97 months

Study Arms (5)

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

EXPERIMENTAL

Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide

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

EXPERIMENTAL

Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide

Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide

EXPERIMENTAL

Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide

Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone

ACTIVE COMPARATOR

Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib

Part 1: Elranatamab + Lenalidomide

EXPERIMENTAL

Drug: Elranatamab; Drug: Lenalidomide

Interventions

Elranatamab DRUG

Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide; Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide; Part 1: Elranatamab + Lenalidomide; Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide

Daratumumab DRUG

Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

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 + Bortezomib + Lenalidomide + Dexamethasone

Lenalidomide DRUG

Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide; Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide; Part 1: Elranatamab + Lenalidomide; Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide; Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone

Bortezomib DRUG

Randomized

Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone

Dexamethasone DRUG

Randomized

Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (Part 1) and ≥1 g/dL (Part 2);
• 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 defined as:
• Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
• Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
• 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.

You may not qualify if:

• 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, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, B3S 0H6, Canada

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510555, China

RECRUITING

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Tongji University - Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality, 200434, China

RECRUITING

The first Affiliated hospital of Wenzhou medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Fakultní nemocnice Brno Bohunice

Brno, Brno-město, 625 00, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

RECRUITING

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, 44093 Cedex 1, France

RECRUITING

Rabin Medical Center

Petah Tikva, Central District, 4910021, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, TELL ABĪB, 6423906, Israel

RECRUITING

Cro-Irccs

Aviano, Friuli Venezia Giulia, 33081, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, 24127, Italy

RECRUITING

Azienda Sanitaria Locale di Pescara

Pescara, 65124, Italy

RECRUITING

AOU Policlinico Umberto I

Roma, 00161, Italy

RECRUITING

Gunma University Hospital

Maebashi, Gunma, 371-8511, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

RECRUITING

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, 150-8935, Japan

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, 40-519, Poland

ACTIVE NOT RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeonranamdo, 58128, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

RECRUITING

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain

NOT YET RECRUITING

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona [barcelona], 08908, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña], 08036, Spain

RECRUITING

Institut Català d'Oncologia (ICO) - Girona

Girona, Girona [gerona], 17007, Spain

RECRUITING

Clinica Universidad de Navarra

Madrid, Madrid, Comunidad de, 28027, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, València, 46017, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

RECRUITING

Hospital La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

NOT YET RECRUITING

China Medical University Hospital

Taichung, 404332, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

ACTIVE NOT RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333, Taiwan

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; Lenalidomide; Dexamethasone; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 21, 2022
• Study Start: November 10, 2022
• Primary Completion (Estimated): October 18, 2030
• Study Completion (Estimated): October 3, 2033
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); CH (1); FR (1); CZ (2); CA (1); JP (4); PL (2); IT (6); IL (2); CN (5); ES (9); AU (1); TW (3)