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)
AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Jupiter Medical Center/Anderson Family Cancer Institute — Jupiter, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (139 Sites)
Showing the first 25 of 139 sites.
- Jupiter Medical Center/Anderson Family Cancer Institute — Jupiter, Florida
- MSK Basking Ridge — Basking Ridge, New Jersey
- MSK Monmouth — Middletown, New Jersey
- MSK Bergen — Montvale, New Jersey
- MSK Commack — Commack, New York
- MSK Westchester — Harrison, New York
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York
- Memorial Sloan Kettering Cancer Center-Main Campus — New York, New York
- MSK Nassau — Uniondale, New York
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Pindara Private Hospital — Benowa, Queensland
- St Vincent's Hospital Melbourne — Fitzroy, Victoria
- Epworth Freemasons — Melbourne, Victoria
- The Alfred Hospital — Melbourne, Victoria
- Epworth Healthcare — Richmond, Victoria
- Universitätsklinikum St. Pölten — Sankt Pölten, Lower Austria
- Krankenhaus der Barmherzigen Schwestern Wien — Vienna, State of Vienna
- Medizinische Universität Graz — Graz, Styria
- Landeskrankenhaus Feldkirch — Rankweil, Vorarlberg
- Uniklinikum Salzburg — Salzburg,
- Medizinische Universität Wien — Vienna,
- Clinique Saint Pierre — Ottignies, Brabant Wallon
- Grand Hôpital de Charleroi — Gilly, Hainaut
- Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi — Yvoir, Namur
- AZ Sint-Jan Brugge-Oostende AV — Bruges, West-vlaanderen
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Myeloma
- Ixazomib + Pomalidomide + Dexamethasone In MM — Boston, Massachusetts
- A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma — Birmingham, Alabama
- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant — Tampa, Florida
- MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb — Beverly Hills, California
- A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma — Phoenix, Arizona
- A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma — Hackensack, New Jersey
Explore by condition: All Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.