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

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eastern Cooperative Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chaim Shustik, MD

Principal Investigator

Royal Victoria Hospital - Montreal

William R. Friedenberg, MD

Principal Investigator

Guthrie Cancer Center at Guthrie Clinic Sayre

Richard A. Larson, MD

Principal Investigator

University of Chicago

Pieter Sonneveld, MD, PhD

Principal Investigator

University Medical Center Rotterdam at Erasmus Medical Center

Karl H. Hanson, MD

Principal Investigator

Saint Luke's Cancer Institute at Saint Luke's Hospital

Eligibility Criteria

Inclusion Criteria

Anemia

Bone marrow plasmacytosis with at least 10% plasma cells, sheets of plasma cells, or biopsy proven plasmacytosis

Myeloma (M) protein in serum and/or urine

Treatment Details

Interventions

• Chemotherapy (Alkylating agents)
• PSC 833 (Modulator)

Chemotherapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana-Farber Cancer Institute Boston, MA

University of Minnesota Cancer Center Minneapolis, MN

New York Presbyterian Hospital - Cornell Campus New York, NY

Cancer Care Ontario-London Regional Cancer Centre London, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Patients Recruited

153,000+

NCIC Clinical Trials Group

Collaborator

Trials

190

Patients Recruited

145,000+

European Organisation for Research and Treatment of Cancer - EORTC

Collaborator

Trials

417

Patients Recruited

166,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Patients Recruited

267,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Patients Recruited

118,000+

Southwest Oncology Group

Collaborator

Trials

389

Patients Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+