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AmyloidosisPhase 2NCT00607581

Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis

A Phase 2 study testing cyclophosphamide, lenalidomide and dexamethasone in people with Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Completed

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

Official record
Search all trials

Trial summary

The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits. The plasma cells can be killed and their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide, steroids, such as dexamethasone, and drugs that stimulate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloidosis
What is being tested?
cyclophosphamide, lenalidomide and dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteItaly
Study dates
Feb 2008to Jan 2012
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

Who may be able to join

  • Diagnosis of AL amyloidosis.
  • Evidence of a monoclonal light chain at serum and/or urine immunofixation electrophoresis.
  • Elevated circulating free light chain (of the type identified by immunofixation) above the upper limit of the normal range and abnormal kappa/lambda ratio.
  • Previously treated and requiring further treatment.
  • Symptomatic organ involvement.
  • Bone marrow plasma cell <30%.
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  • Echocardiographic ejection fraction >40%.
  • Troponin I <0.1 ng/mL.
  • Hemoglobin >10 g/dL.
  • Absolute neutrophil count >1500/uL.
  • Platelet count >140000/uL.
  • Total bilirubin <2.5 mg/dL.
  • Alkaline phosphatase <4 x upper reference limit (u.r.l.).
  • ALT <3 x u.r.l..
  • Glomerular filtration rate >30 mL/min.
  • Performance status ECOG 1-3.
  • Female subjects of childbearing potential must have two negative pregnancy tests prior to starting study drug.

Who cannot join

  • Prior treatment with the association of cyclophosphamide, lenalidomide and dexamethasone or with lenalidomide.
  • Requirement for other concomitant chemotherapy, immunotherapy or radiotherapy, or any investigational ancillary therapy.
  • Presence of other active malignancies, with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate specific antigen is within normal limits.
  • Clinically overt multiple myeloma.
  • Uncontrolled infection.
  • New York Heart Association (NYHA) class 4 heart failure.
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  • Enzyme documented myocardial infarction within 6 months before enrollment.
  • Grade 2 or 3 atrioventricular block (Mobitz type I is permitted).
  • Repetitive ventricular arrhythmias at 24 h Holter electrocardiogram in spite of treatment with amiodarone.
  • Supine systolic blood pressure <90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of >20 mmHg in spite of being treated for orthostatic hypotension.
  • Prior history of thrombosis or venous thromboembolism or pulmonary embolism. Prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.
  • Indication to receive clopidogrel, ticlopidine or warfarin.
  • Factor X level <20%.
  • Poorly controlled diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months).
  • Previous or ongoing psychiatric illness (with the exclusion of reactive depression).
  • Pregnant or nursing women.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Amyloidosis Research and Treatment Center - Fondazione IRCCS Policlinico San Matteo

    Pavia, Pavia, 27100

Other trials in Italy

About this study

Official title: An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis

The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits. The plasma cells can be killed and their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide, steroids, such as dexamethasone, and drugs that stimulate the immune system, such as lenalidomide.

The present trial studies the efficacy and safety of the combination of cyclophosphamide, lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated and need further therapy.

Read the detailed description

This study will include previously treated patients with AL amyloidosis.

Primary objectives to determine the hematologic and organ response rate to the association of cyclophosphamide, lenalidomide and dexamethasone (CLD).

Secondary objectives

  • to determine the safety of CLD,
  • to determine time to response to CLD,
  • to determine the duration of response to CLD,
  • to assess survival of AL amyloidosis patients treated with CLD.

Patients receive 28-day cycles cyclophosphamide on days 1, 8 and 15, oral lenalidomide on days 1-21 and oral dexamethasone on days 1, 8, 15, and 22.

Up to 9 courses can be performed until one of the following endpoints is met:

  • completion of cycle 9,
  • complete hematologic remission observed after cycle 3 or 6,
  • partial hematologic response associated with organ response after cycle 6.
  • no response at cycle 3 or 6. After completion of study treatment, patients are followed every 3 months for up to 3 years.
Conditions
Amyloidosis
Keywords
amyloidosis, lenalidomide, cyclophosphamide, dexamethasone
Medical subject headings
Amyloidosis

What participants receive

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

  • cyclophosphamideDrug

    Also called Endoxan, D003520

    cyclophosphamide: 500 mg orally on days 1, 8, 15

  • lenalidomideDrug

    Also called Revlimid, CC 5013, C467567

    lenalidomide: 15 mg orally on days 1-21

  • dexamethasoneDrug

    Also called Soldesam, D003907

    dexamethasone: 40 mg orally on days on days 1, 8, 15, 22

Study groups in NCT00607581
Study groupRoleWhat they receive
1ExperimentalThe participants receive up to 9 28-day cycles of * cyclophosphamide: 500 mg orally on days 1, 8, 15; * lenalidomide: 15 mg orally on days 1-21; * dexamethasone: 40 mg orally on days on days 1, 8, 15, 22.
Receives: Drug: cyclophosphamide; Drug: lenalidomide; Drug: dexamethasone

What is being measured

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

  1. hematologic response rate

    Measured: at 3 months

Secondary outcomes (5)

  1. organ response rate

    Measured: at 3 months

  2. time to response

    Measured: every 28 days

  3. time to progression

    Measured: every 3 months for 3 years

  4. survival

    Measured: up to 3 years after treatment discontinuation

  5. toxicity

    Measured: continuous during treatment

Timeline

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

  1. First posted5 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionDec 2011
  4. Study completionJan 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607581
Sponsor's protocol ID
AC-003-IT
Other IDs
RV-AMYL-PI-303
Status last verified
Feb 2012
First submitted
22 Jan 2008
Last updated
10 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Wechalekar AD, Goodman HJ, Lachmann HJ, Offer M, Hawkins PN, Gillmore JD. Safety and efficacy of risk-adapted cyclophosphamide, thalidomide, and dexamethasone in systemic AL amyloidosis. Blood. 2007 Jan 15;109(2):457-64. doi: 10.1182/blood-2006-07-035352. Epub 2006 Sep 21.

    PubMed 16990593

  • Palladini G, Perfetti V, Perlini S, Obici L, Lavatelli F, Caccialanza R, Invernizzi R, Comotti B, Merlini G. The combination of thalidomide and intermediate-dose dexamethasone is an effective but toxic treatment for patients with primary amyloidosis (AL). Blood. 2005 Apr 1;105(7):2949-51. doi: 10.1182/blood-2004-08-3231. Epub 2004 Nov 30.

    PubMed 15572585

  • Dispenzieri A, Lacy MQ, Zeldenrust SR, Hayman SR, Kumar SK, Geyer SM, Lust JA, Allred JB, Witzig TE, Rajkumar SV, Greipp PR, Russell SJ, Kabat B, Gertz MA. The activity of lenalidomide with or without dexamethasone in patients with primary systemic amyloidosis. Blood. 2007 Jan 15;109(2):465-70. doi: 10.1182/blood-2006-07-032987. Epub 2006 Sep 28.

    PubMed 17008538

  • Sanchorawala V, Wright DG, Rosenzweig M, Finn KT, Fennessey S, Zeldis JB, Skinner M, Seldin DC. Lenalidomide and dexamethasone in the treatment of AL amyloidosis: results of a phase 2 trial. Blood. 2007 Jan 15;109(2):492-6. doi: 10.1182/blood-2006-07-030544. Epub 2006 Sep 7.

    PubMed 16960148

  • Merlini G, Stone MJ. Dangerous small B-cell clones. Blood. 2006 Oct 15;108(8):2520-30. doi: 10.1182/blood-2006-03-001164. Epub 2006 Jun 22.

    PubMed 16794250

  • Palladini G, Russo P, Milani P, Foli A, Lavatelli F, Nuvolone M, Perlini S, Merlini G. A phase II trial of cyclophosphamide, lenalidomide and dexamethasone in previously treated patients with AL amyloidosis. Haematologica. 2013 Mar;98(3):433-6. doi: 10.3324/haematol.2012.073593. Epub 2012 Sep 14.

    PubMed 22983583

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, lenalidomide and dexamethasone in people with Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. 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 10 Feb 2012. 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 Italy. 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?

hematologic response rate (time frame: at 3 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 NCT00607581, which also lists 6 linked publications.

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 10 Feb 2012.

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