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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCenter for International Blood and Marrow Transplant Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Allogeneic Hematopoietic Stem Cell Transplant

    Other intervention

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

Treatment groups

544 Participants
are divided into 2 treatment groups
Group A: Allogeneic HCT1 intervention
Group B: Historical autoHCT0 interventions

Trial outcomes

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

Time frame
5 years post transplant

Secondary outcomes

1

Progression-free survival (PFS)

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

Time frame
5 years post transplant
2

Relapse or progression

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

Time frame
5 years post transplant
3

Transplant related mortality

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

Time frame
5 years post transplant
4

Incidence of acute GVHD

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

Time frame
5 years post transplant

Other outcomes

Sponsors and contacts

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