sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

NCT03956615 | Completed Results

• 1 other identifier: UZBRU_MUM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.

  Reporting of the relative amount of patients for whom such sdAb could be successfully obtained

  Within 2 years after study completion

• Amount of Paraprotein-targeting sdAbs Generated Per Patient

  Absolute amount of unique sdAbs obtained per patient

  Within 2 years after study completion

Study Arms (1)

Clinically Suspected or Pathologically Confirmed Multiple Myeloma.

OTHER

Patients with a clinically suspected or pathologically confirmed multiple myeloma.

Other: Blood sampling and bone marrow analysis

Interventions

Blood sampling and bone marrow analysis OTHER

Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)

Clinically Suspected or Pathologically Confirmed Multiple Myeloma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will only be included in the study if they meet all of the following criteria:
• Patients who have given informed consent
• Patients at least 18 years old
• Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma.

You may not qualify if:

• Patients will not be included in the study if one of the following criteria applies:
• Patients who cannot communicate reliably with the investigator
• Patients who are unlikely to cooperate with the requirements of the study
• Patients at increased risk of death from a pre-existing concurrent illness
• Patients who participated already in part I of this study

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Stichting tegen Kanker: collaborator

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Matthias D'Huyvetter
• Organization: Vrije Universiteit Brussel

afspraak_nucleaire@uzbrussel.be

+3224776013

Study Officials

• Marleen Keyaerts, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 21, 2019
• Study Start: February 12, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)