Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals Birmingham NHS Foundation Trust
Coordinator of this site? Confirm its status
BirminghamUnited KingdomUnknown status
The Royal Marsden NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust NIHR
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Royal Marsden NHS Foundation Trust
Coordinator of this site? Confirm its status
SurreyUnited KingdomUnknown status
National Cancer Center Hospital
Coordinator of this site? Confirm its status
Chuo KuJapanUnknown status
Kobe City Medical Center General Hospital
Coordinator of this site? Confirm its status
KobeJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
Nagoya City University Hospital
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Japanese Red Cross Medical Center
Coordinator of this site? Confirm its status
Shibuya-kuJapanUnknown status
China Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
The Regents of the University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Texas Oncology South Austin
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
St. David's South Austin Medical Center
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
MSK Basking Ridge.
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Cleveland Clinic Taussig Cancer Institute
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
MSK Commack.
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Henry Ford Hospital
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Cancer Care & Hematology - Fort Collins
Coordinator of this site? Confirm its status
Fort CollinsUnited StatesUnknown status
Poudre Valley Hospital
Coordinator of this site? Confirm its status
Fort CollinsUnited StatesUnknown status
Poudre Valley Health System (PVHS)
Coordinator of this site? Confirm its status
Fort CollinsUnited StatesUnknown status
UF Health Shands Hospital Pharmacy Investigational Drug Service - Main
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
UF Health Shands Hospital
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
UF Health Shands Cancer Hospital
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
UCHealth Cancer Care & Hematology - Greeley
Coordinator of this site? Confirm its status
GreeleyUnited StatesUnknown status
MSK Westchester.
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Coordinator of this site? Confirm its status
Long Island CityUnited StatesUnknown status
UCHealth Cancer Care & Hematology - Loveland
Coordinator of this site? Confirm its status
LovelandUnited StatesUnknown status
East Jefferson General Hospital Bone Marrow Transplant Clinic
Coordinator of this site? Confirm its status
MetairieUnited StatesUnknown status
East Jefferson General Hospital
Coordinator of this site? Confirm its status
MetairieUnited StatesUnknown status
MSK Monmouth.
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
MSK Bergen.
Coordinator of this site? Confirm its status
MontvaleUnited StatesUnknown status
Tulane University
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Mayo Clinic Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
Methodist Plaza Clinical Trials Office
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Methodist Hospital Investigational Pharmacy
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Methodist Healthcare System of San Antonio dba Methodist Hospital
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Blood Cancer and Stem Cell Transplant Clinic
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status
MSK Nassau.
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.