CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

Celgene

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: CDC-501

Study type

Interventional

Funder types

Industry

Identifiers

CC-5013-MM-007

Details and patient eligibility

About

The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.
Subject must understand and voluntarily sign an informed consent document.
Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline
ECOG (Zubrod) performance status of 0 to 2.
Subject must be able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.