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
  Purpose

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.


Condition Intervention Phase
Amyloidosis
Drug: CC-5013
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 38
Study Start Date: April 2005
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166413

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Angela Dispenzieri, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Angela Dispenzieri, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00166413     History of Changes
Other Study ID Numbers: 1105-04, MC0484, 1105-04
Study First Received: September 12, 2005
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014