Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 3 Completed Eastern Cooperative Oncology Group Cancer and Leukemia Group B · collab European Organisation for Research and Treatment of Cancer - EORTC · collab NCIC Clinical Trials Group · collab National Cancer Institute (NCI) · collab SWOG Cancer Research Network · collab

RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with chemotherapy may reduce resistance to the drug, and allow more tumor cells to be killed. It is not yet known whether combination chemotherapy plus PSC 833 is more effective than combination chemotherapy alone in treating patients with relapsed or refractory multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma.

Timeline

Start: 1997-06-30
Primary completion: 2003-04
Completion: —

Outcome

Missed primary endpoint

paper CONCLUSION: The addition of the MDR-modulating agent valspodar to VAD did not improve treatment outcome. PMID 16419071 ↗

Publications

Results Friedenberg WR, Rue M, Blood EA, Dalton WS, Shustik C, Larson RA, Sonneveld P, Greipp PR. Phase III study of PSC-833 (valspodar) in combination with vincristine, doxorubicin, and dexamethasone (valspodar/VAD) versus VAD alone in patients with recurring or refractory multiple myeloma (E1A95): a trial of the Eastern Cooperative Oncology Group. Cancer. 2006 Feb 15;106(4):830-8. doi: 10.1002/cncr.21666.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	—	Oral
Subject	Doxorubicin	Other / unclassified	—	Intravenous
Subject	Vincristine	Small molecule	—	Intravenous
Subject	valspodar	Protein / enzyme biologic	—	Oral