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AmyloidosisPhase 2NCT00166413

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

A Phase 2 study testing CC-5013 in people with Amyloidosis, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloidosis
What is being tested?
CC-5013
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
Apr 2005to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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
  1. ECOG performance status (PS) 0, 1, 2, or 3
  2. >=18 years of age
  3. 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
  1. 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
  2. Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function
  3. Ability to provide informed consent
  4. Anticipated life expectancy of at least 3 months
  5. 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Conditions
Amyloidosis
Being tested
CC-5013
Medical subject headings
Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-5013Drug

    Also called amino substituted analog of thalidomide

    40 mg/day orally on days 1-4 and 15-18 of each 28-day cycle

Study groups in NCT00166413
Study groupRoleWhat they receive
CC5013ExperimentalAssess the proportion of confirmed hematologic responses (HCR, HPR) resulting from treatment with CC5013 after 3 months in patients with primary systemic amyloidosis.
Receives: Drug: CC-5013

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis

    Measured: 12 months

Secondary outcomes (5)

  1. Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone

    Measured: 12 months

  2. Hematologic response rate of CC-5013 and dexamethasone

    Measured: 12 months

  3. Organ response of CC-5013 and the CC-5013 dexamethasone combination

    Measured: 12 months

  4. Time to progression

    Measured: 5 years

  5. Survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00166413
Sponsor's protocol ID
1105-04
Other IDs
MC0484, 1105-04
Status last verified
May 2011
First submitted
12 Sep 2005
Last updated
6 May 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-5013 in people with Amyloidosis, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00166413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2011.

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