NCT05712967

Brief Summary

Goal of this observational, non-interventional study is to demonstrate that in humans a correlation exists between bone marrow (BM) levels of the cytokine interleukin 17 (IL-17) and composition of the gut microbiota in patients affected by smoldering multiple myeloma (SMM) or multiple myeloma (MM). Enrolled SMM/MM patients will be analyzed for their bone marrow levels of IL-17 together with the distribution of T helper 17 lymphocytes in their BM and peripheral blood. These analyses will be correlated with analyses of the patients' gut microbiome to identify commensal bacteria potentially involved in Th17 cell expansion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

4.6 years

First QC Date

December 23, 2022

Last Update Submit

February 29, 2024

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • the role of microbiota and IL17 in MM

    This study will provide direct evidence that the human gut microbiota modulate BM Th17 cells and MM progression . It will also provide the ground for a larger prospective clinical study on the predictive value of BM IL-17 in SMM patients.

    5YRS

Study Arms (3)

PATIENTS WITH MM

patients fulfilling the International Myeloma Working Group (IMWG) diagnostic criteria for MM

PATIENTS WITH sMM

patients fulfilling the International Myeloma Working Group (IMWG) diagnostic criteria for SMM

Controls

healthy controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

52 patients fulfilling the International Myeloma Working Group (IMWG) diagnostic criteria for SMM or MM, and 10 healthy controls older than 18 years and accepting to sign the informed consent

You may qualify if:

  • patients fulfilling the International Myeloma Working Group (IMWG) diagnostic criteria for SMM or MM, and 10 healthy controls older than 18 years and accepting to sign the informed consent

You may not qualify if:

  • Non-Caucasian subjects.
  • Subjects younger than 18 years.
  • Subjects that did not accept to sign the informed consent.
  • Subjects reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy or prophylaxis.
  • Subjects who already underwent HSCT or under pharmacologic therapy for MM.
  • Subjects affected by autoimmune diseases with the exception of thyroiditis.
  • Subjects affected by HIV, HBV or HCV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Related Publications (4)

  • Anderson KC, Carrasco RD. Pathogenesis of myeloma. Annu Rev Pathol. 2011;6:249-74. doi: 10.1146/annurev-pathol-011110-130249.

    PMID: 21261519BACKGROUND

  • Kyle RA, Larson DR, Therneau TM, Dispenzieri A, Kumar S, Cerhan JR, Rajkumar SV. Long-Term Follow-up of Monoclonal Gammopathy of Undetermined Significance. N Engl J Med. 2018 Jan 18;378(3):241-249. doi: 10.1056/NEJMoa1709974.

    PMID: 29342381BACKGROUND

  • Rajkumar SV, Landgren O, Mateos MV. Smoldering multiple myeloma. Blood. 2015 May 14;125(20):3069-75. doi: 10.1182/blood-2014-09-568899. Epub 2015 Apr 2.

    PMID: 25838344BACKGROUND

  • Korde N, Roschewski M, Zingone A, Kwok M, Manasanch EE, Bhutani M, Tageja N, Kazandjian D, Mailankody S, Wu P, Morrison C, Costello R, Zhang Y, Burton D, Mulquin M, Zuchlinski D, Lamping L, Carpenter A, Wall Y, Carter G, Cunningham SC, Gounden V, Sissung TM, Peer C, Maric I, Calvo KR, Braylan R, Yuan C, Stetler-Stevenson M, Arthur DC, Kong KA, Weng L, Faham M, Lindenberg L, Kurdziel K, Choyke P, Steinberg SM, Figg W, Landgren O. Treatment With Carfilzomib-Lenalidomide-Dexamethasone With Lenalidomide Extension in Patients With Smoldering or Newly Diagnosed Multiple Myeloma. JAMA Oncol. 2015 Sep;1(6):746-54. doi: 10.1001/jamaoncol.2015.2010.

    PMID: 26181891BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Isolation of plasma and cells from human blood and bone marrow samples. Feces samples collection

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • matteo bellone, md

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 23, 2022

First Posted

February 6, 2023

Study Start

June 14, 2019

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

IT(1)