A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

Celgene

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: B (Placebo + Dexamethasone)

Drug: A (Thalidomide + Dexamethasone)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00057564

THAL-MM-003

Details and patient eligibility

About

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Enrollment

470 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Active Multiple Myeloma Stage II or III Durie Salmon
Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity

Exclusion criteria

Pregnant or lactating females
Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
Prior history of malignancy unless subject has been free of disease for ≥ 3 years
Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L)
Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)
Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) >3.0 x upper limit of normal (ULN)
Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)