Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166413
First received: September 12, 2005
Last updated: May 5, 2011
Last verified: May 2011

September 12, 2005
May 5, 2011
April 2005
December 2006   (final data collection date for primary outcome measure)
To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis
Complete list of historical versions of study NCT00166413 on ClinicalTrials.gov Archive Site
  • Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Hematologic response rate of CC-5013 and dexamethasone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Organ response of CC-5013 and the CC-5013 dexamethasone combination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone
  • Hematologic response rate of CC-5013 and dexamethasone
  • Organ response of CC-5013 and the CC-5013 dexamethasone combination
  • Time to progression
  • Survival
Not Provided
Not Provided
 
Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis
A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis

Patients with primary systemic amyloidosis will be treated with CC-5013 (lenalidomide; Revlimid) as a single agent for 3 months. If their disease worsens or does not improve during that time frame dexamethasone will be added to the treatment program.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyloidosis
Drug: CC-5013
40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle
Other Name: amino substituted analog of thalidomide
Experimental: CC5013
Assess the proportion of confirmed hematologic responses (HCR, HPR) resulting from treatment with CC5013 after 3 months in patients with primary systemic amyloidosis.
Intervention: Drug: CC-5013
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
Not Provided
December 2006   (final data collection date for primary outcome measure)
  1. Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens and immunohistochemical proof of AL
  2. Measurable disease of AL amyloidosis as defined by one of the following:

    • Serum monoclonal protein >=1.0 g by protein electrophoresis
    • >200 mg of monoclonal protein in the urine on 24 hour electrophoresis
    • Serum immunoglobulin free light chain & >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  3. ECOG performance status (PS) 0, 1, 2, or 3
  4. >=18 years of age
  5. The following laboratory values obtained <=14 days prior to registration:

    • Creatinine < = 3 mg/dL
    • Absolute neutrophil count >=1000/microliter
    • Platelet >=75000/microliter
    • Hemoglobin > = 8.0 g/dL
  6. Symptomatic organ involvement with amyloid to justify therapy. This could include liver involvement, cardiac involvement, renal involvement, peripheral neuropathy grade 1, or soft tissue involvement. Must have more than purpura or carpal tunnel syndrome
  7. Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function
  8. Ability to provide informed consent
  9. Anticipated life expectancy of at least 3 months
  10. None of the following:

    • Pregnant women or women of reproductive ability who are unwilling to use effective contraception
    • Nursing women
    • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
    • Myelosuppressive chemotherapy < 4 weeks prior to registration
    • Concomitant high dose corticosteroids
    • Grade 2 (or higher) peripheral neuropathy
    • Uncontrolled infection
    • Clinically overt multiple myeloma
    • Active malignancy
    • Prior hypersensitivity reaction to Thalidomide
    • Syncope within the past 30 days
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166413
1105-04, MC0484, 1105-04
Yes
Angela Dispenzieri, M.D., Mayo Clinic Cancer Center
Mayo Clinic
Not Provided
Principal Investigator: Angela Dispenzieri, M.D. Mayo Clinic
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP