Clinical Trials Logo
  1. Home
  2. Multiple Myeloma
  3. NCT04467281
  4. Details
NCT04467281 Clinical Trial

A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04467281
Other study ID # 20-098
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date June 30, 2020
Est. completion date February 26, 2021

Study information
Verified date June 2022
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with PET/CT scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. We also want to see if 89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if they can better locate any leftover disease following treatment compared to the standard imaging methods.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 26, 2021
Est. primary completion date February 26, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Age = 21 years - Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma - At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment - ECOG performance status 0 to 2 - Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf). Exclusion Criteria: - Life expectancy < 12 months - Pregnancy or lactation - Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds. - History of anaphylactic reaction to humanized or human antibodies. - Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 89Zr-DFO-daratumumab
Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.
Diagnostic Test:
• PET/CT
Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Outcome
Type Measure Description Time frame Safety issue
Primary number of patient's with positive tumors Uptake of FDG PET/CT 1 year
Secondary assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response. 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

External Links