MMRD: Multiple Myeloma Minimal Residual Disease

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02627261
• Collaborator: Janssen, LP (Industry)
• Enrollment: 100
• Locations: 3
• Duration (Months): 78
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Biological: blood samples and bone marrow aspirates will be collected

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma
• Study Start Date: Nov 1, 2015
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; 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)

Outcome Measures

Primary Outcome Measures

1. Quantification of residual disease [Residual disease is assessed up to 18 months after inclusion]

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

Secondary Outcome Measures

1. kinetic of variation of the residual tumor cells detected by flow cytometry method [18 months]

   % positive cells in bone marrow sample

2. kinetic of variation of the residual tumor cells detected by new generation sequencing method [18 months]

   % positive in bone marrow sample

3. kinetic of variation of the circulating tumor cells [18 months]

   number of cells / mL of blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ≥ 18 years

• previously undiagnosed myeloma

• eligible for high dose therapy and bone marrow transplantation

• signed consent

Exclusion Criteria:

• ongoing therapy for another neoplasia

• Patients with other hematologic malignancies,

• patients deprived of liberty for administrative or judicial reasons

• previously treated for myeloma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Huriez	Lille		France	59037
2	Centre Hospitalier Universitaire Hôtel-Dieu de Nantes	Nantes		France	44000
3	Centre Hospitalier Lyon Sud	Pierre Bénité		France	69495

Sponsors and Collaborators

• Hospices Civils de Lyon
• Janssen, LP

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02627261
• Other Study ID Numbers: 69HCL15_0316
• First Posted: Dec 10, 2015
• Last Update Posted: Aug 1, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hospices Civils de Lyon: residual disease
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 1, 2017