Multiple Myeloma Minimal Residual Disease

NCT02627261 | Completed

• 1 other identifier: 69HCL15_0316
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease

Conditions

Multiple Myeloma

Keywords

residual disease

Outcome Measures

Primary Outcomes (1)

• Quantification of residual disease

  study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection

  Residual disease is assessed up to 18 months after inclusion

Secondary Outcomes (3)

• kinetic of variation of the residual tumor cells detected by flow cytometry method

  18 months

• kinetic of variation of the residual tumor cells detected by new generation sequencing method

  18 months

• kinetic of variation of the circulating tumor cells

  18 months

Study Arms (1)

patients with multiple myeloma

blood samples and bone marrow aspirates will be collected in patients at different time point

Biological: blood samples and bone marrow aspirates will be collected

Interventions

blood samples and bone marrow aspirates will be collected BIOLOGICAL

Serial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation)

patients with multiple myeloma

Eligibility Criteria

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

Study Population

This study will focus on adult patients with multiple myeloma and who will receive a treatment with high-dose melphalan and autologous bone marrow transplantation

You may qualify if:

• ≥ 18 years
• previously undiagnosed myeloma
• eligible for high dose therapy and bone marrow transplantation
• signed consent

You may not qualify if:

• ongoing therapy for another neoplasia
• Patients with other hematologic malignancies,
• patients deprived of liberty for administrative or judicial reasons
• previously treated for myeloma

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Janssen, LP: collaborator

Study Sites (3)

Hôpital Huriez

Lille, 59037, France

Location

Centre Hospitalier Universitaire Hôtel-Dieu de Nantes

Nantes, 44000, France

Location

Centre Hospitalier Lyon Sud

Pierre Bénité, 69495, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

a gene sequencing technology will be used on bone marrow samples to detect residual disease

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 10, 2015
• Study Start: November 23, 2015
• Primary Completion: September 2, 2018
• Study Completion: September 2, 2018
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)