Relapsed Refractory Multiple Myeloma (RRMM) Clinical Trials

Find Relapsed Refractory Multiple Myeloma (RRMM) Clinical Trials Near You

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.

Status: Recruiting
Location: See all (143) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria

• Documented evidence of measurable disease:

‣ Serum M-protein level ≥ 1 g/dL

⁃ Urine M-protein level ≥ 200 mg/24h

⁃ Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio

• Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy

• Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy

• Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.

• ECOG performance status score of 0 to 1

• Adequate hematology and chemistry laboratory values:

‣ Haemoglobin ≥ 8.0 g/dL

⁃ Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3)

⁃ Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells

⁃ Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)

⁃ Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

Locations
United States
Arizona
Research Site
NOT_YET_RECRUITING
Gilbert
Research Site
WITHDRAWN
Phoenix
Research Site
NOT_YET_RECRUITING
Tucson
California
Research Site
WITHDRAWN
La Jolla
Research Site
NOT_YET_RECRUITING
Sacramento
Research Site
NOT_YET_RECRUITING
Santa Monica
Colorado
Research Site
RECRUITING
Denver
Connecticut
Research Site
RECRUITING
New Haven
Washington, D.c.
Research Site
NOT_YET_RECRUITING
Washington D.c.
Florida
Research Site
WITHDRAWN
Coral Gables
Research Site
NOT_YET_RECRUITING
Tampa
Georgia
Research Site
RECRUITING
Atlanta
Iowa
Research Site
WITHDRAWN
Iowa City
Illinois
Research Site
NOT_YET_RECRUITING
Chicago
Research Site
NOT_YET_RECRUITING
Park Ridge
Kansas
Research Site
NOT_YET_RECRUITING
Kansas City
Kentucky
Research Site
RECRUITING
Louisville
Massachusetts
Research Site
WITHDRAWN
Boston
Research Site
NOT_YET_RECRUITING
Boston
Research Site
NOT_YET_RECRUITING
Boston
Michigan
Research Site
WITHDRAWN
Detroit
Research Site
WITHDRAWN
Detroit
Minnesota
Research Site
WITHDRAWN
Rochester
North Carolina
Research Site
NOT_YET_RECRUITING
Chapel Hill
Research Site
RECRUITING
Charlotte
Research Site
NOT_YET_RECRUITING
Charlotte
Research Site
NOT_YET_RECRUITING
Winston-salem
Research Site
RECRUITING
Winston-salem
New York
Research Site
NOT_YET_RECRUITING
Albany
Research Site
WITHDRAWN
New York
Research Site
WITHDRAWN
New York
Research Site
RECRUITING
New York
Research Site
RECRUITING
New York
Research Site
WITHDRAWN
Rochester
Research Site
WITHDRAWN
The Bronx
Ohio
Research Site
NOT_YET_RECRUITING
Cincinnati
Research Site
NOT_YET_RECRUITING
Cleveland
Oregon
Research Site
NOT_YET_RECRUITING
Portland
South Carolina
Research Site
WITHDRAWN
Charleston
Tennessee
Research Site
RECRUITING
Nashville
Texas
Research Site
RECRUITING
Austin
Research Site
NOT_YET_RECRUITING
Dallas
Research Site
RECRUITING
Houston
Utah
Research Site
NOT_YET_RECRUITING
Salt Lake City
Virginia
Research Site
WITHDRAWN
Charlottesville
Research Site
NOT_YET_RECRUITING
Gainesville
Research Site
WITHDRAWN
Richmond
Washington
Research Site
NOT_YET_RECRUITING
Puyallup
Research Site
RECRUITING
Seattle
Wisconsin
Research Site
NOT_YET_RECRUITING
Madison
Research Site
RECRUITING
Milwaukee
Other Locations
Australia
Research Site
RECRUITING
Camperdown
Research Site
RECRUITING
Darlinghurst
Research Site
RECRUITING
Fitzroy
Research Site
NOT_YET_RECRUITING
Liverpool
Research Site
RECRUITING
Melbourne
Research Site
RECRUITING
Melbourne
Research Site
NOT_YET_RECRUITING
Murdoch
Brazil
Research Site
RECRUITING
Salvador
Research Site
RECRUITING
São Paulo
Research Site
RECRUITING
São Paulo
Canada
Research Site
NOT_YET_RECRUITING
Calgary
Research Site
RECRUITING
Montreal
Research Site
RECRUITING
Toronto
Research Site
NOT_YET_RECRUITING
Vancouver
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Changchun
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Chongqing
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Hefei
Research Site
NOT_YET_RECRUITING
Nanchang
Research Site
NOT_YET_RECRUITING
Nanchang
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
NOT_YET_RECRUITING
Ningbo
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shenzhen
Research Site
NOT_YET_RECRUITING
Tianjin
Research Site
NOT_YET_RECRUITING
Wenzhou
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Xi'an
Research Site
NOT_YET_RECRUITING
Xi'an
Research Site
NOT_YET_RECRUITING
Zhengzhou
Research Site
NOT_YET_RECRUITING
Zhengzhou
France
Research Site
NOT_YET_RECRUITING
Lille
Research Site
NOT_YET_RECRUITING
Nantes
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Pierre-bénite
Research Site
NOT_YET_RECRUITING
Poitiers
Research Site
NOT_YET_RECRUITING
Toulouse
Germany
Research Site
NOT_YET_RECRUITING
Berlin
Research Site
NOT_YET_RECRUITING
Dresden
Research Site
NOT_YET_RECRUITING
Erlangen
Research Site
NOT_YET_RECRUITING
Essen
Research Site
NOT_YET_RECRUITING
Freiburg Im Breisgau
Research Site
RECRUITING
Hamburg
Research Site
NOT_YET_RECRUITING
Leipzig
Research Site
NOT_YET_RECRUITING
Mainz
Research Site
NOT_YET_RECRUITING
München
Research Site
NOT_YET_RECRUITING
Nuremberg
Research Site
NOT_YET_RECRUITING
Würzburg
Italy
Research Site
NOT_YET_RECRUITING
Bologna
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Naples
Research Site
NOT_YET_RECRUITING
Rozzano
Research Site
NOT_YET_RECRUITING
Torino
Japan
Research Site
RECRUITING
Bunkyō City
Research Site
RECRUITING
Kashiwa
Research Site
RECRUITING
Kyoto
Research Site
RECRUITING
Nagoya
Research Site
RECRUITING
Shibuya-ku
Research Site
RECRUITING
Shinjuku-ku
Norway
Research Site
RECRUITING
Oslo
Poland
Research Site
NOT_YET_RECRUITING
Gdansk
Research Site
RECRUITING
Gliwice
Research Site
NOT_YET_RECRUITING
Lublin
Research Site
NOT_YET_RECRUITING
Poznan
Research Site
NOT_YET_RECRUITING
Warsaw
Research Site
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Pamplona
Research Site
NOT_YET_RECRUITING
Salamanca
Research Site
RECRUITING
Santander
Research Site
NOT_YET_RECRUITING
Valencia
Taiwan
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
United Kingdom
Research Site
RECRUITING
Birmingham
Research Site
RECRUITING
Bristol
Research Site
NOT_YET_RECRUITING
Glasgow, Scotland
Research Site
RECRUITING
London
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2030-07-29
Participants
Target number of participants: 508
Treatments
Experimental: Arm A
AZD0120
Active_comparator: Arm B
1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

Similar Clinical Trials