NCT03127761

Brief Summary

Multiple myeloma (MM) is the second most common hematologic malignancy in adults. The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). Allogeneic HCT (alloHCT) is the only potentially curative therapy available to patients with MM. However, the significant morbidity and mortality of this procedure historically limited its application in older patients. Thus, although potentially curative, standard risk MM patients have excellent prognoses in the era of novel therapies which reduces the overall benefit of alloHCT. However, because the outcomes for high-risk MM remain poor despite the best available standard therapies (overall survival of 24-36 months), initial data suggest that alloHCT should be explored in this subset.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
544

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Jul 2017

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 Progress82%
Jul 2017Apr 2028

First Submitted

Initial submission to the registry

April 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

9.8 years

First QC Date

April 18, 2017

Last Update Submit

August 29, 2023

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Compare five-year survival

    Compare five-year overall survival between the alloHCT cohort and an age and disease risk matched cohort of autoHCT patients

    5 years post transplant

Secondary Outcomes (5)

  • Progression-free survival (PFS)

    5 years post transplant

  • Relapse or progression

    5 years post transplant

  • Transplant related mortality

    5 years post transplant

  • Incidence of acute GVHD

    5 years post transplant

  • Incidence of chronic GVHD

    5 years post transplant

Study Arms (2)

Allogeneic HCT

Prospectively enrolled cohort of patients receiving allogeneic hematopoietic cell transplantation for multiple myeloma

Other: Allogeneic Hematopoietic Stem Cell Transplant

Historical autoHCT

Historical cohort of patients with autologous hematopoietic cell transplantation between 2010 and 2016

Interventions

Allogeneic Hematopoietic Stem Cell TransplantOTHER

This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of matched autoHCT controls.

Allogeneic HCT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A prospective cohort study of approximately 544 patients receiving allogeneic HCT for multiple myeloma in CIBMTR centers in the US matched to a historical control patients treated with autoHCT between 2010 and 2016

You may qualify if:

  • Medicare beneficiary
  • Stage II or III multiple myeloma and/or primary plasma cell leukemia
  • Eligible to receive an allogeneic HCT from any suitable allogeneic donor (as determined by the transplant center) including umbilical cord blood
  • Will receive allogeneic HCT at a US transplant center
  • Agree to submit comprehensive clinical data on their pre- and post-transplant clinical status and outcomes to the CIBMTR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for International Blood and Marrow Transplant Research

Minneapolis, Minnesota, 55401, United States

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 Officials

  • Anita D'Souza, MD, MS

    CIBMTR, Medical College of Wisconsin

    STUDY CHAIR

  • Parameswaran Hari, MD, MS

    CIBMTR, Medical College of Wisconsin

    STUDY CHAIR

Central Study Contacts

Mona Patel

CONTACT

414-805-0655mopatel@mcw.edu

Study Design

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

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 25, 2017

Study Start

July 25, 2017

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)