Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03127761

Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for International Blood and Marrow Transplant Research

Minneapolis, Minnesota, 55401, United States

Location status: Recruiting

Location contact

Michael Tierney

CONTACT

[email protected]

About this study

Multiple myeloma (MM) is the second most common hematologic malignancy in adults. Overall survival (OS) in MM has improved significantly in the last 15 years with the emergence of novel therapies such as thalidomide, bortezomib and lenalidomide. The median life expectancy of patients with MM treated in the current era is more than 6 years, while SEER data from a slightly earlier time period (2008-12) estimated the 5 year survival at 48.5%. However, prognosis is not uniform and varies considerably based on a presenting features and response to therapy.

The current standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an autologous HCT (autoHCT). There is controversy regarding the timing of autoHCT after initial novel therapy induction with randomized trials showing similar OS whether done early or delayed to time of relapse as salvage therapy. However, more recent trials comparing early versus delayed transplant support the benefit of early upfront 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. Current data from the Center for International Blood and Marrow Research (CIBMTR) show transplant-related mortality rates of 23 (20-26)% at 5 years with myeloablative conditioning.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic Hematopoietic Stem Cell Transplant

Other

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

Primary outcomes

  1. Compare five-year survival

    Time frame: 5 years post transplant

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

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 5 years post transplant

    five-year PFS probabilities between the AlloHCT cohort and an age and disease risk matched cohort of autoHCT patients

  2. Relapse or progression

    Time frame: 5 years post transplant

    Myeloma recurrence or progression will be defined per International Myeloma Working Group (IMWG) guidelines

  3. Transplant related mortality

    Time frame: 5 years post transplant

    Death from any cause within 28 days after alloHCT or death in the absence of progression/relapse of MM after day 28 post transplant

  4. Incidence of acute GVHD

    Time frame: 5 years post transplant

    Occurrence of Grade I, II and III/IV skin, gastrointestinal, or liver abnormalities fulfilling the Consensus criteria of Grades II-IV acute GVHD

  5. Incidence of chronic GVHD

    Time frame: 5 years post transplant

    Occurrence of symptoms in any organ system fulfilling the criteria of chronic GVHD

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Patel

CONTACT

[email protected]

414-805-0655

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

  • National Marrow Donor Program

Registry information

Official study title

Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma: A Study to Develop Evidence of Effectiveness for the Centers for Medicare and Medicaid Services (CMS)

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2017
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.