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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

Criteria

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)