NCT06541860

Brief Summary

Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Aug 2023Aug 2028

Study Start

First participant enrolled

August 21, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2028

Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4.5 years

First QC Date

April 9, 2024

Last Update Submit

August 2, 2024

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy.

    Phase I - Retrospective study The primary objective is to estimate 2-year progression-free survival (PFS) of PVd when used in RRMM after anti-CD38 MoAb and IMIDS Phase II - Prospective study The primary objective is to estimate the 2-year progression-free survival (PFS) of the on-label combinations in patients with relapsed RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.

You may qualify if:

  • Phase I
  • Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme
  • Patients aged ≥ 18 years
  • Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data
  • Phase II
  • Patients with RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS started on therapy with on-label schemes
  • Patients aged ≥ 18 years
  • Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data

You may not qualify if:

  • Patients not willing to consent to review of clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs San Matteo Pavia

Pavia, PV, 27100, Italy

RECRUITING

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 Design

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

Study Record Dates

First Submitted

April 9, 2024

First Posted

August 7, 2024

Study Start

August 21, 2023

Primary Completion (Estimated)

February 21, 2028

Study Completion (Estimated)

August 21, 2028

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations

IT(1)