This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05028348 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Stichting European Myeloma Network |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Recruiting |
Countries | France, Germany, Greece, Italy, Netherlands, Spain, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Experimental: Selinexor, pomalidomide and dexamethasone (SPd)
Selinexor will be given as an oral dose: 40 mg (2 20 mg tablets) once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle. Patients ≤75 years: o Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion. Patients > 75 years: Dexamethasone will be given as an oral 20 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
Active Comparator: Elotuzumab, Pomalidomide and Dexamethasone (EloPd)
Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle. Pomalidomide will be given as an oral 4 mg dose once a day (QD) on Days 1 to 21 of each 28-day cycle. Patients ≤75 years: Dexamethasone 28 mg PO + 8 mg IV on days of elotuzumab dosing Dexamethasone 40 mg PO on non-elotuzumab days (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion. Patients >75 years: Dexamethasone 8 mg PO + 8 mg IV on days of elotuzumab dosing Dexamethasone 20 mg PO on non-elotuzumab dosing weeks (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
Drug: - Selinexor
Selinexor will be given as an oral dose 40 mg (2 20 mg tablets) QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Drug: - Elotuzumab
Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle.
Drug: - Pomalidomide
Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.
Drug: - Dexamethasone Oral
Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Preferred dosing of dexamethasone is 40 mg QW for patients who are ≤75 years of age (20 mg QW for >75-year-old patients at the Investigator's discretion) before QW dosing of selinexor, however, it may be divided over 2 days at the Investigator's discretion.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Status
Not yet recruiting
Address
University of California, San Francisco
Fresno, California, 93701
Status
Not yet recruiting
Address
Kaiser Permanente Southern California
Irvine, California, 92618
Status
Recruiting
Address
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017
Status
Recruiting
Address
Berenson Oncology
West Hollywood, California, 90069
Status
Recruiting
Address
The Oncology Institute of Hope and Innovation
Whittier, California, 90602
Status
Not yet recruiting
Address
UCHealth Cancer Center - Harmony Campus
Fort Collins, Colorado, 80528
Status
Not yet recruiting
Address
Florida Cancer Specialists South
Fort Myers, Florida, 33901
Status
Not yet recruiting
Address
Florida Cancer Specialists North
Saint Petersburg, Florida, 33705
Status
Not yet recruiting
Address
Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308
Status
Not yet recruiting
Address
Florida Cancer Specialists East
West Palm Beach, Florida, 33401
Status
Recruiting
Address
Hawaii Cancer Care
Honolulu, Hawaii, 96813
Status
Not yet recruiting
Address
June E. Nylen Cancer Center
Sioux City, Iowa, 51101
Status
Recruiting
Address
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
Status
Recruiting
Address
American Oncology Partners of Maryland
Bethesda, Maryland, 20817
Status
Not yet recruiting
Address
Ascension St. John Hospital
Grosse Pointe Woods, Michigan, 48236
Status
Recruiting
Address
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska, 68506
Status
Recruiting
Address
Cancer Care Specialists
Reno, Nevada, 89511
Status
Not yet recruiting
Address
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103-1461
Status
Not yet recruiting
Address
East Carolina University
Greenville, North Carolina, 27834
Status
Not yet recruiting
Address
Novant Health Cancer Institute
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania, 19611
Status
Not yet recruiting
Address
Medical University of South Carolina. Hollings Cancer Center
Charleston, South Carolina, 29425
Status
Not yet recruiting
Address
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Status
Recruiting
Address
Renovatio Clinical Research
The Woodlands, Texas, 77380
Status
Not yet recruiting
Address
CHRU Hôpital Claude Huriez
Lille, ,
Status
Recruiting
Address
CHRU Hôtel Dieu
Nantes, ,
Status
Not yet recruiting
Address
CHU Hôpital Saint Antoine
Paris, ,
Status
Not yet recruiting
Address
La Pitié
Paris, ,
Status
Not yet recruiting
Address
Paris Necker
Paris, ,
Status
Not yet recruiting
Address
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, ,
Status
Not yet recruiting
Address
Pôle IUCT Oncopole CHU
Toulouse, ,
Status
Not yet recruiting
Address
Universitätsklinikum Hamburg - Eppendorf
Hamburg, ,
Status
Not yet recruiting
Address
University Hospital of Heidelberg
Heidelberg, ,
Status
Not yet recruiting
Address
University Hospital of Cologne
Köln, ,
Status
Not yet recruiting
Address
University Hospital of Münster
Münster, ,
Status
Not yet recruiting
Address
University Hospital of Würzburg
Würzburg, ,
Status
Recruiting
Address
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, ,
Status
Recruiting
Address
General Hospital of Athens"Evangelismos"
Athens, ,
Status
Not yet recruiting
Address
St Savvas Cancer Hospital
Athens, ,
Status
Not yet recruiting
Address
University General Hospital of Patras
Patras, ,
Status
Not yet recruiting
Address
Theagenion Cancer Hospital
Thessaloníki, ,
Status
Not yet recruiting
Address
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona
Ancona, ,
Status
Not yet recruiting
Address
A.O. Papa Giovanni XXIII
Bergamo, ,
Status
Not yet recruiting
Address
Bologna
Bologna, ,
Status
Not yet recruiting
Address
ASST Spedali Civili di Brescia - Ematologia
Brescia, ,
Status
Not yet recruiting
Address
Brescia
Brescia, ,
Status
Not yet recruiting
Address
Ospedale Oncologico 'A. Businco'
Cagliari, ,
Status
Not yet recruiting
Address
Az.Osp. Di Careggi_Dh ematologia
Firenze, , 50134
Status
Not yet recruiting
Address
A.O.U. Policlinico S. Martino - Ematologia
Genova, ,
Status
Not yet recruiting
Address
Hospital IRST
Meldola, ,
Status
Not yet recruiting
Address
A.O.U. Policlinico 'G. Martino'
Messina, ,
Status
Not yet recruiting
Address
A.O.U. Maggiore della Carità di Novara
Novara, , 28100
Status
Not yet recruiting
Address
Ospedale S. Eugenio
Roma, ,
Status
Not yet recruiting
Address
A.O. S. Maria
Terni, ,
Status
Not yet recruiting
Address
A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
Torino, , 10126
Status
Not yet recruiting
Address
Azienda Ospedaliera Universitaria di Udine
Udine, ,
Status
Not yet recruiting
Address
Amphia ziekenhuis
Breda, ,
Status
Not yet recruiting
Address
Erasmus MC
Rotterdam, ,
Status
Recruiting
Address
Hospital Clinic I Provincial de Barcelona
Barcelona, ,
Status
Recruiting
Address
Institut Catala D Oncolocia Hospitalet - Hospital Duran i Reynals
Barcelona, ,
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, ,
Status
Recruiting
Address
H. General Universitario Morales Meseguer
Murcia, ,
Status
Recruiting
Address
Clínica Universidad de Navarra (CUN)
Pamplona, ,
Status
Not yet recruiting
Address
Hospital Universitario de Salamanca
Salamanca, ,
Status
Recruiting
Address
H. Universitario Marqués de Valdecilla
Santander, ,
Status
Recruiting
Address
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago De Compostela, ,
Status
Recruiting
Address
H.U. La Fe
Valencia, ,