CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
melphalan +3 moredrug
Likely dose
Melphalan IV; recombinant interferon alfa SC; aldesleukin with IL-2-treated autologous or syngeneic PBSC infusionAI-extracted
Key inclusion· 4
  • Age <70 years
  • Advanced multiple myeloma (stage II/III at diagnosis, or stage I with progression/failure to respond)
  • Eligible for mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF per protocol 506.03, or prior adequate PBSC collection
  • For syngeneic donation: donor and patient documented as syngeneic (ABO typing, HLA typing, VNTR studies); donor >20 kg; donor meets eligibility per Standard Practice Guidelines
Key exclusion· 18
  • Age ≥70 years
  • Karnofsky score <80
  • Left ventricular ejection fraction <50%, or history of congestive heart disease, MI, coronary artery disease, or arrhythmia
  • Total bilirubin >1.5 mg/mL (unless Gilbert's disease history)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006244
NCT00006244Phase 2Completed

Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma

Fred Hutchinson Cancer Center·interventional·Posted Jan 27, 2003·Updated Jul 12, 2017

In Brief

A Phase 2 clinical trial evaluating melphalan, recombinant interferon alfa, and 2 other interventions for Refractory Multiple Myeloma and 3 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartFeb 1, 2000
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 16.2 yearsPosted 23.4 years ago

Interventions

melphalandrug

Given IV

recombinant interferon alfabiological

Given SC

aldesleukinbiological

Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion

in vitro-treated peripheral blood stem cell transplantationprocedure

Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion