NCT05014412CompletedPhase 2
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 3 Aug 2021
- Start date
- 7 Oct 2021
- Primary completion date
- 15 Jun 2023
- Lead sponsor
- Pfizer
- Diseases
- Multiple myeloma
- NCT number
- NCT05014412
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 86
- From 7 Oct 2021 to the primary completion date, 15 Jun 2023
- 50 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Stem cell transplant within 12 weeks prior to enrollment or active GVHD
- 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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
- Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
- Live attenuated vaccine within 4 weeks of the first dose
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Other illness
- POEMS syndrome
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
- Known or suspected hypersensitivity to the study intervention, or any of its excipients
Other
- Smoldering multiple myeloma
- Active Plasma cell leukemia
- Amyloidosis
- Waldenström's macroglobulinemia
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
Who the study is looking for
- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
- Measurable disease, as defined by at least 1 of the following:
- Serum M-protein \>0.5 g/dL by SPEP
- Urinary M-protein excretion \>200 mg/24 hours by UPEP
- Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- Refractory to at least one IMiD
- Refractory to at least one PI
- Refractory to at least one anti-CD38 antibody
- Relapsed/refractory to last anti-myeloma regimen
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust NIHR Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Surrey | United Kingdom | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| The Regents of the University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Texas Oncology South Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| St. David's South Austin Medical Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| MSK Basking Ridge. Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Cleveland Clinic Taussig Cancer Institute Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| MSK Commack. Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Cancer Care & Hematology - Fort Collins Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| Poudre Valley Hospital Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| Poudre Valley Health System (PVHS) Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| UF Health Shands Hospital Pharmacy Investigational Drug Service - Main Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| UF Health Shands Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| UF Health Shands Cancer Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| UCHealth Cancer Care & Hematology - Greeley Coordinator of this site? Confirm its status | Greeley | United States | Unknown status |
| MSK Westchester. Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy Coordinator of this site? Confirm its status | Long Island City | United States | Unknown status |
| UCHealth Cancer Care & Hematology - Loveland Coordinator of this site? Confirm its status | Loveland | United States | Unknown status |
| East Jefferson General Hospital Bone Marrow Transplant Clinic Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| East Jefferson General Hospital Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| MSK Monmouth. Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| MSK Bergen. Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Methodist Plaza Clinical Trials Office Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Hospital Investigational Pharmacy Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Healthcare System of San Antonio dba Methodist Hospital Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Blood Cancer and Stem Cell Transplant Clinic Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| MSK Nassau. Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
Related publications
- Elranatamab Population Pharmacokinetics and Exposure-Response for Cytokine Release Syndrome in Patients with Relapsed or Refractory Multiple Myeloma.Clin Pharmacokinet · 2026 · PMID 42287565
This page is information, not medical advice. Discuss any trial with your doctor.