CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
filgrastim +7 morebiological
Likely dose
High-dose melphalan followed by busulfan/cyclophosphamide with peripheral blood stem cell rescueAI-extracted
Key inclusion· 8
  • Histologically proven stage I-III multiple myeloma
  • Less than 18 months since diagnosis
  • Responding or stable disease after induction therapy with no greater than 40% bone marrow involvement
  • Age 65 years or younger
Key exclusion· 7
  • Waldenstrom's macroglobulinemia
  • Prior malignancy within past 5 years except nonmelanomatous skin cancer or cervical carcinoma in situ
  • HIV positive
  • Hepatitis B antigen or hepatitis C RNA positive

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

Search/NCT00004088
NCT00004088Phase 2Completed

Sequential High-Dose Melphalan and Busulfan/Cyclophosphamide Followed by Peripheral Blood Progenitor Cell Rescue, Interferon/Thalidomide and Pamidronate for Patients With Multiple Myeloma

City of Hope Medical Center·interventional·Posted Jan 27, 2003·Updated Jul 2, 2019

In Brief

A Phase 2 clinical trial evaluating filgrastim, recombinant interferon alfa, and 6 other interventions for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 77 participants across 2 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.

Study Details

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

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartApr 13, 1999
Primary CompletionJan 9, 2018
TodayJul 2, 2026
Enrollment to primary: 18.7 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

recombinant interferon alfabiological

busulfandrug

cyclophosphamidedrug

melphalandrug

pamidronate disodiumdrug

thalidomidedrug

peripheral blood stem cell transplantationprocedure