Recruiting

Allogeneic HCT

Sponsor:

Center for International Blood and Marrow Transplant Research

Code:

NCT03127761

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Allogeneic Hematopoietic Stem Cell Transplant

Study Details

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.

Conditions

Multiple Myeloma

Study ID

NCT03127761

Start date

Jul 25, 2017

Status verified date

Aug, 2023

Completion date

Apr, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

544 participants

Anticipated

Interventions and Outcome Measures

Arms

Allogeneic HCT

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

Historical autoHCT

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

Interventions

Allogeneic Hematopoietic Stem Cell Transplant

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

Primary outcome measure

  • Compare five-year survival [ Time Frame: 5 years post transplant ]

Central Contacts and Locations

Central contacts

Locations

Center for International Blood and Marrow Transplant Research

Recruiting

Minneapolis, Minnesota, United States, 55401

Contacts

Michael Tierney

DatabaseIRB@NMDP.org

More Information

Sponsor

Center for International Blood and Marrow Transplant Research

Last update posted

Aug 30, 2023

Last verified

Aug, 2023

Keywords

  • Multiple Myeloma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for International Blood and Marrow Transplant Research on 2023-08-30.