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Phase 3 N=363 Treatment

Autologous Transplant for Multiple Myeloma

Multiple Myeloma

Enrolled (actual)
363
Serious AEs
0.5%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants Achieving a Complete Response — 51 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Stem Cell Transplant (Procedure); Cyclophosphamide + Mesna (Drug); Melphalan (Drug); Granulocyte-colony stimulating factor (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Masonic Cancer Center, University of Minnesota
Primary completion
Aug 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Achieving a Complete Response
123
PRIMARY
Number of Participants Achieving a Complete Response
123
PRIMARY
Number of Participants Achieving a Complete Response
123
SECONDARY
Number of Patients With Extended Disease-free Survival
164
SECONDARY
Number of Participants With Overall Survival
301
SECONDARY
Number of Participants With Overall Survival
301
SECONDARY
Number of Participants With Overall Survival
301
SECONDARY
Count of Participants Experiencing Transplant Related Mortality
3
SECONDARY
Number of Participants Experiencing Incidence of Relapse
69
SECONDARY
Number of Participants With Disease Progression
34
SECONDARY
Time to Progression
159.4
SECONDARY
Time to Relapse
182.9
SECONDARY
Number of Participants With Absolute Neutrophil Recovery
363
SECONDARY
Time to Attainment of CR
4.6
SECONDARY
Time to Attainment of CR+PR
4.3
SECONDARY
Duration of Maintenance Treatment
SECONDARY
Dropout Rate From Maintenance Therapy
SECONDARY
Number of Participants With Toxicities
68
SECONDARY
Number of Participants With Infections
68

Summary

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

Eligibility Criteria

Inclusion Criteria

  • Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:
  • After initial therapy in either first complete or partial remission or no objective response
  • After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
  • Is not eligible or has refused any protocols of higher priority
  • 18 - 75 years of age
  • Adequate organ function defined as:
  • Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
  • Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan
  • Hepatic: bilirubin 50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
  • Performance status: Karnofsky performance of > 80%.
  • Free of active uncontrolled infection at the time of study entry.
  • At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
  • Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria

  • Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
  • Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00177047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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