A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

Study Purpose

The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.

Recruitment Criteria

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
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Participant has a history of RRMM, and must:
  • - Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy.
  • - Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy.

Exclusion Criteria:

• Must not have previously received alnuctamab or mezigdomide. Note: Other protocol-defined inclusion/exclusion criteria apply

Trial Details

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.

NCT06163898
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 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, France, Germany, Israel, Netherlands, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part A

Experimental: Arm B1

Experimental: Arm B2

Experimental: Arm C1

Experimental: Arm C2

Interventions

Drug: - Alnuctamab

Specified dose on specified days

Drug: - Mezigdomide

Specified dose on specified days

Drug: - Dexamethasone

Specified dose on specified days

Contact a Trial Team

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Luciano Costa, Site 0033

Clinical.Trials@bms.com

205-934-9695

Local Institution - 0032, San Francisco, California

Status

Not yet recruiting

Address

Local Institution - 0032

San Francisco, California, 94143

Site Contact

Site 0032

Clinical.Trials@bms.com

855-907-3286

New Haven, Connecticut

Status

Recruiting

Address

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, 06511

Site Contact

Noffar Bar, Site 0035

Clinical.Trials@bms.com

000-000-0000

Weill Cornell Medical College, New York, New York

Status

Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

Site Contact

Ruben Niesvizky, Site 0018

Clinical.Trials@bms.com

646-258-0156

International Sites

Local Institution - 0004, Aarhus, Midtjylland, Denmark

Status

Not yet recruiting

Address

Local Institution - 0004

Aarhus, Midtjylland, 8200

Site Contact

Site 0004

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0007, Odense, Syddanmark, Denmark

Status

Not yet recruiting

Address

Local Institution - 0007

Odense, Syddanmark, 5000

Site Contact

Site 0007

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0008, Lille, Nord, France

Status

Not yet recruiting

Address

Local Institution - 0008

Lille, Nord, 59000

Site Contact

Site 0008

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0009, Nantes, Pays-de-la-Loire, France

Status

Not yet recruiting

Address

Local Institution - 0009

Nantes, Pays-de-la-Loire, 44000

Site Contact

Site 0009

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0027, Paris, France

Status

Not yet recruiting

Address

Local Institution - 0027

Paris, , 75010

Site Contact

Site 0027

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0037, Essen, Nordrhein-Westfalen, Germany

Status

Not yet recruiting

Address

Local Institution - 0037

Essen, Nordrhein-Westfalen, 45122

Site Contact

Site 0037

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0036, Heidelberg, Germany

Status

Not yet recruiting

Address

Local Institution - 0036

Heidelberg, , D-69120

Site Contact

Site 0036

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0038, Wuerzburg, Germany

Status

Not yet recruiting

Address

Local Institution - 0038

Wuerzburg, , 97080

Site Contact

Site 0038

Clinical.Trials@bms.com

855-907-3286

Rabin Medical Center, Petah-Tikva, HaMerkaz, Israel

Status

Recruiting

Address

Rabin Medical Center

Petah-Tikva, HaMerkaz, 4910021

Site Contact

Iuliana Vaxman, Site 0021

Clinical.Trials@bms.com

972547994003

Sheba Medical Center, Ramat Gan, HaMerkaz, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, HaMerkaz, 5262100

Site Contact

Hila Magen, Site 0030

Clinical.Trials@bms.com

972504065462

Hadassah Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Center

Jerusalem, , 9112001

Site Contact

Moshe Gatt, Site 0020

Clinical.Trials@bms.com

97226779268

Local Institution - 0044, Rotterdam, Zuid-Holland, Netherlands

Status

Not yet recruiting

Address

Local Institution - 0044

Rotterdam, Zuid-Holland, 3015 CE

Site Contact

Site 0044

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0029, Groningen, Netherlands

Status

Not yet recruiting

Address

Local Institution - 0029

Groningen, , 9713 GZ

Site Contact

Site 0029

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0039, Málaga, Andalucía, Spain

Status

Not yet recruiting

Address

Local Institution - 0039

Málaga, Andalucía, 29010

Site Contact

Site 0039

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0023, Santander, Cantabria, Spain

Status

Not yet recruiting

Address

Local Institution - 0023

Santander, Cantabria, 39008

Site Contact

Site 0023

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0025, Pamplona, Navarra, Spain

Status

Not yet recruiting

Address

Local Institution - 0025

Pamplona, Navarra, 31008

Site Contact

Site 0025

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0028, Salamanca, Spain

Status

Not yet recruiting

Address

Local Institution - 0028

Salamanca, , 37007

Site Contact

Site 0028

Clinical.Trials@bms.com

855-907-3286