Multiple Myeloma
Conditions
Keywords
Newly Diagnosed Multiple Myeloma, Multiple Myeloma
Brief 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
Interventions
DRUGA (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
DRUGB (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Sponsors
Celgene Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to tumor progression (TTP) | Up to 3 years | Time to tumor progression (TTP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who survived | Up to 3 years | Number of patients who survived |
| Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) | Up to 3 years | Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) |
| Myeloma response rate | Up to 3 years | Myeloma response determination criteria developed by Bladé et al 1998 |
| Number of participants with adverse events | Up to 3 years | Number of participants with adverse events |
Countries
Australia, Belgium, Bulgaria, Canada, Germany, Hungary, Ireland, Israel, Italy, Poland, Russia, Spain, Switzerland, Ukraine, United Kingdom, United States
Outcome results
None listed