Clinical Trial for Multiple Myeloma.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Multiple Myeloma

Sex

Male or Female

Age

18+ years

Healthy participants

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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 (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.

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, 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.

Study overview

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.

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0500

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37 sites found

AOU Policlinico Umberto I

Roma, Italy, 00161

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Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy, 56126

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

Turin, Piedmont, Italy, 10126

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Azienda Sanitaria Locale di Pescara

Pescara, Italy, 65124

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Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Italy, 24127

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

Nantes, France, 44093 Cedex 1

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Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan, 333

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China Medical University Hospital

Taichung, Taiwan, 404332

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Chonnam National University Hwasun Hospital

Hwasun-gun, Jeonranamdo, South Korea, 58128

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Clinica Universidad de Navarra

Madrid, Madrid, Comunidad de, Spain, 28027

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Cro-Irccs

Aviano, Friuli Venezia Giulia, Italy, 33081

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Fakultní nemocnice Brno Bohunice

Brno, Brno-město, Czechia, 625 00

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

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Gunma University Hospital

Maebashi, Gunma, Japan, 371-8511

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Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña], Spain, 08036

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Hospital La Princesa

Madrid, Spain, 28006

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Hospital San Pedro de Alcántara

Cáceres, Spain, 10003

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Hospital Universitario Doctor Peset

Valencia, València, Spain, 46017

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Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain, 28040

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Institut Català d'Oncologia (ICO) - Girona

Girona, Girona [gerona], Spain, 17007

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Institut Català d'Oncologia - L'Hospitalet

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

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Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan, 150-8935

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Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3S 0H6

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Rabin Medical Center

Petah Tikva, Central District, Israel, 4910021

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Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea, 13620

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Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan, 411-8777

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Sourasky Medical Center

Tel Aviv, TELL ABĪB, Israel, 6423906

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St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510555

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The first Affiliated hospital of Wenzhou medical University

Wenzhou, Zhejiang, China, 325000

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Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

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

Wuhan, Hubei, China, 430030

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Tongji University - Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality, China, 200434

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Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland, 80-214

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Vseobecna fakultni nemocnice v Praze

Prague, Czechia, 12808

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CHUS - Hospital Clinico Universitario

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

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Kantonsspital Winterthur

Winterthur, Switzerland, 8401

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Join PfizerConnect

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

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

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

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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