AmyloidosisPhase 1/2NCT00981708
Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)
A Phase 1/2 study testing Lenalidomide, Dexamethasone and Cyclophosphamide in people with Amyloidosis, run by University of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to determine the safety and activity of the combination of lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with primary systemic (AL ) amyloidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Lenalidomide, Dexamethasone and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2008to 11 Jan 2016
- Phase
- Phase 1/2
- 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
- Understand and voluntarily sign an informed consent form.
- Age >=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Confirmed diagnosis of AL amyloidosis (see appendix 3)
- Need for treatment in the judgment of their treating physician
- Evaluable or measurable disease defined by any of the following:
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- Measurable serum free light chains >= 10 mg/dL, kappa or lambda, provided kappa/lambda ratio is abnormal (measurable disease)
- Monoclonal protein in the serum >= 1 g/dL
- ECOG Performance Status (PS) 0, 1, 2 or 3
- Laboratory test results within these ranges:
- Absolute neutrophil count >= 1.5 x 109/L
- Platelet count >= 100 x 109/L
- Serum creatinine >= 2.5 mg/dL
- Total bilirubin >= 1.5 mg/dL
- AST (SGOT) and ALT (SGPT) > 2 x ULN or > 5 x ULN if hepatic metastases are present.
- Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. (See Appendix 1 Pregnancy Testing Guidelines and Acceptable Birth Control Methods.)
- Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).
Who cannot join
- Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis (Appendix 3)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type A, B or C.
- > grade 2 peripheral neuropathy
- Life expectancy < 3 months
- Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or equivalent corticosteroids for concurrent illness or adrenal replacement therapy
Trial locations and contacts
1 site in 1 country.
Greece1 site
Alexandra Hospital , Department of Clinical Therapeutics
Athens, Attica, 115 28
About this study
Official title: A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis
The purpose of this study is to determine the safety and activity of the combination of lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with primary systemic (AL ) amyloidosis.
Read the detailed description
Primary systemic amyloidosis (AL) is a plasma cell dyscrasia where amyloid fibrils are formed by monoclonal immunoglobulin light chains and deposit in various organs causing tissue damage and dysfunction. It is a rare disease with an incidence of 8 patients per million per year. Virtually all patients die of this disease with a median survival of 12-18 months and less than approximately 5% surviving 10 years. The current therapeutic approach to systemic amyloidosis is based on the observation that amyloid deposits can be reabsorbed and organ function can be restored if the concentration of the amyloidogenic precursor is reduced. The recognized standard treatment for patients with amyloidosis is alkylating agent-based chemotherapy - some selected patients can be treated with high dose melphalan with autologous stem cell transplantation. Recent studies have led to an improved understanding of the biology of plasma cells. Interactions between the bone marrow microenvironment and plasma cells have a critical growth regulating influence on myeloma cells. Thalidomide has shown significant activity in multiple myeloma patients with relapsing or refractory disease and even more in newly diagnosed patients. However, thalidomide causes somnolence, fatigue, constipation, and peripheral neuropathy and is not well tolerated in patients with AL amyloidosis. Lenalidomide is a small molecule structurally related to thalidomide with potent immunomodulatory effects. Lenalidomide has been found to be significantly active in relapsed multiple myeloma both in vitro and in Phase I, II and III clinical trials, including patients who had previously failed thalidomide. Unlike thalidomide, lenalidomide causes no significant sedation, constipation, neuropathy, or rash. Deep vein thrombosis ,especially in combination with dexamethasone, has been reported . Combination of thalidomide with with alkylating agents (such as melphalan or cyclophosphamide) have been very active in patients with myeloma and have superior activity than combinations of alkylating agents with steroids alone. However, the toxicity profile of thalidomide is problematic for this combination in patients with AL. combinations of lenalidomide with alkylating agents (Melphalan + prednisone +Lenalidomide)are feasible and very active in patients with multiple myeloma. Cyclophosphamide has a more favorable toxicity profile than melphalan when used in oral combinations with dexamethasone and thalidomide. However, given the remarkable antimyeloma activity of lenalidomide, overall improved toxicity profile of lenalidomide compared with thalidomide and a need for improved treatments for this incurable malignancy, the combinations of lenalidomide are worthy of study. Preliminary data from Mayo clinic using CC-5013 and dexamethasone demonstrates that lenalidomide is tolerable and has activity in patients with AL amyloidosis and may be useful in patients with AL amyloidosis who either are not candidates for high dose chemotherapy and peripheral blood stem cell transplantation or who have failed prior therapies. Efficacy and tolerability of oral cyclophosphamide , combined with dexamethasone and thalidomide, is well documented in patients with refractory or relapsed multiple myeloma while this combination has been used in patients with AL amyloidosis . Intermediate dose dexamethasone is tolerable and without significant toxicity in patients with AL amyloidosis . The combination of alkylating agents with thalidomide and dexamethasone has been effective in patients with AL amyloidosis . The combination of an alkylating agent with Lenalidomide and intermediate dose dexamethasone may lead to more rapid hematologic responses than either agent alone , and subsequently may lead to increased organ response rates . Therefore, in this phase I/II trial we explore the safety and efficacy of the combination of the alkylating agent cyclophosphamide to lenalidomide and intermediate dose dexamethasone in patients who are no candidates for high dose melphalan chemotherapy with autologous stem cell transplantation.
- Conditions
- Amyloidosis
- Being tested
- Lenalidomide, Dexamethasone and Cyclophosphamide
- Keywords
- Amyloidosis, lenalidomide, newly diagnosed, relapsed, primary systemic AL amyloidosis
- Medical subject headings
- Amyloidosis, Recurrence, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide, Dexamethasone and CyclophosphamideDrug
Also called Revlimid, Endoxan, Dexamethasone
Lenalidomide capsules on days 1 to 21. the dose starts at 5 mg/day up to 25 mg/day.
Dexamethasone tablets on days 1 to 4. Dose 20 mg per day.
Cyclophosphamide tablets on days 1 to 10. The dose starts at 50 mg per day up to 100 mg per day.
The cycle is to be repeated every 28 days (4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Lenalidomide, Dexamethasone and cyclophosphamide Receives: Drug: Lenalidomide, Dexamethasone and Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the maximum tolerated dose of lenalidomide and cyclophosphamide and assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis.
Maximum Tolerated Dose
Measured: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response
Secondary outcomes (1)
To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis and organ response rate
Toxicity
Measured: Monthly for toxicity and every 3-6 months for organ response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startFeb 2008
- Primary completion11 Jan 2011
- Study completion11 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Cooperative Oncology Group
- Responsible party
- Principal investigator, Meletios A. Dimopoulos, University of Athens
- Investigators
- Meletios A Dimopoulos, MD, Principal investigator, University of Athens, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981708
- Sponsor's protocol ID
- RV-178
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2009
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gavriatopoulou M, Garcia-Sanz R, Kastritis E, Morel P, Kyrtsonis MC, Michalis E, Kartasis Z, Leleu X, Palladini G, Tedeschi A, Gika D, Merlini G, Sonneveld P, Dimopoulos MA. BDR in newly diagnosed patients with WM: final analysis of a phase 2 study after a minimum follow-up of 6 years. Blood. 2017 Jan 26;129(4):456-459. doi: 10.1182/blood-2016-09-742411. Epub 2016 Nov 21.
PubMed 27872060Dimopoulos MA, Garcia-Sanz R, Gavriatopoulou M, Morel P, Kyrtsonis MC, Michalis E, Kartasis Z, Leleu X, Palladini G, Tedeschi A, Gika D, Merlini G, Kastritis E, Sonneveld P. Primary therapy of Waldenstrom macroglobulinemia (WM) with weekly bortezomib, low-dose dexamethasone, and rituximab (BDR): long-term results of a phase 2 study of the European Myeloma Network (EMN). Blood. 2013 Nov 7;122(19):3276-82. doi: 10.1182/blood-2013-05-503862. Epub 2013 Sep 4.
PubMed 24004667Kastritis E, Terpos E, Roussou M, Gavriatopoulou M, Pamboukas C, Boletis I, Marinaki S, Apostolou T, Nikitas N, Gkortzolidis G, Michalis E, Delimpasi S, Dimopoulos MA. A phase 1/2 study of lenalidomide with low-dose oral cyclophosphamide and low-dose dexamethasone (RdC) in AL amyloidosis. Blood. 2012 Jun 7;119(23):5384-90. doi: 10.1182/blood-2011-12-396903. Epub 2012 Apr 18.
PubMed 22517904
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT00981708
- Acronym / sponsor ID
- RV-178
- Conditions
- Amyloidosis
- Keywords
- Amyloidosis, lenalidomide, newly diagnosed, relapsed, primary systemic AL amyloidosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Hellenic Cooperative Oncology Group
- Study start
- Feb 2008
- Primary completion
- 11 Jan 2011 (actual)
- Study completion
- 11 Jan 2016 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and activity of the combination of lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with primary systemic (AL ) amyloidosis.
Detailed description
Primary systemic amyloidosis (AL) is a plasma cell dyscrasia where amyloid fibrils are formed by monoclonal immunoglobulin light chains and deposit in various organs causing tissue damage and dysfunction. It is a rare disease with an incidence of 8 patients per million per year. Virtually all patients die of this disease with a median survival of 12-18 months and less than approximately 5% surviving 10 years. The current therapeutic approach to systemic amyloidosis is based on the observation that amyloid deposits can be reabsorbed and organ function can be restored if the concentration of the amyloidogenic precursor is reduced. The recognized standard treatment for patients with amyloidosis is alkylating agent-based chemotherapy - some selected patients can be treated with high dose melphalan with autologous stem cell transplantation. Recent studies have led to an improved understanding of the biology of plasma cells. Interactions between the bone marrow microenvironment and plasma cells have a critical growth regulating influence on myeloma cells. Thalidomide has shown significant activity in multiple myeloma patients with relapsing or refractory disease and even more in newly diagnosed patients. However, thalidomide causes somnolence, fatigue, constipation, and peripheral neuropathy and is not well tolerated in patients with AL amyloidosis. Lenalidomide is a small molecule structurally related to thalidomide with potent immunomodulatory effects. Lenalidomide has been found to be significantly active in relapsed multiple myeloma both in vitro and in Phase I, II and III clinical trials, including patients who had previously failed thalidomide. Unlike thalidomide, lenalidomide causes no significant sedation, constipation, neuropathy, or rash. Deep vein thrombosis ,especially in combination with dexamethasone, has been reported . Combination of thalidomide with with alkylating agents (such as melphalan or cyclophosphamide) have been very active in patients with myeloma and have superior activity than combinations of alkylating agents with steroids alone. However, the toxicity profile of thalidomide is problematic for this combination in patients with AL. combinations of lenalidomide with alkylating agents (Melphalan + prednisone +Lenalidomide)are feasible and very active in patients with multiple myeloma. Cyclophosphamide has a more favorable toxicity profile than melphalan when used in oral combinations with dexamethasone and thalidomide. However, given the remarkable antimyeloma activity of lenalidomide, overall improved toxicity profile of lenalidomide compared with thalidomide and a need for improved treatments for this incurable malignancy, the combinations of lenalidomide are worthy of study. Preliminary data from Mayo clinic using CC-5013 and dexamethasone demonstrates that lenalidomide is tolerable and has activity in patients with AL amyloidosis and may be useful in patients with AL amyloidosis who either are not candidates for high dose chemotherapy and peripheral blood stem cell transplantation or who have failed prior therapies. Efficacy and tolerability of oral cyclophosphamide , combined with dexamethasone and thalidomide, is well documented in patients with refractory or relapsed multiple myeloma while this combination has been used in patients with AL amyloidosis . Intermediate dose dexamethasone is tolerable and without significant toxicity in patients with AL amyloidosis . The combination of alkylating agents with thalidomide and dexamethasone has been effective in patients with AL amyloidosis . The combination of an alkylating agent with Lenalidomide and intermediate dose dexamethasone may lead to more rapid hematologic responses than either agent alone , and subsequently may lead to increased organ response rates . Therefore, in this phase I/II trial we explore the safety and efficacy of the combination of the alkylating agent cyclophosphamide to lenalidomide and intermediate dose dexamethasone in patients who are no candidates for high dose melphalan chemotherapy with autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Lenalidomide, Dexamethasone and CyclophosphamideLenalidomide, Dexamethasone and cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Understand and voluntarily sign an informed consent form.
- Age >=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Confirmed diagnosis of AL amyloidosis (see appendix 3)
- Need for treatment in the judgment of their treating physician
Key exclusion criteria (13 listed)
- Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis (Appendix 3)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide, Dexamethasone and CyclophosphamideAlso: Revlimid, Endoxan, DexamethasoneLenalidomide capsules on days 1 to 21. the dose starts at 5 mg/day up to 25 mg/day. Dexamethasone tablets on days 1 to 4. Dose 20 mg per day. Cyclophosphamide tablets on days 1 to 10. The dose starts at 50 mg per day up to 100 mg per day. The cycle is to be repeated every 28 days (4 weeks) | Drug | Treatment |
Primary outcome
To assess the maximum tolerated dose of lenalidomide and cyclophosphamide and assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis.
Time frame: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response
Maximum Tolerated Dose
1 secondary outcome
To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis and organ response rate
Time frame: Monthly for toxicity and every 3-6 months for organ response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 27872060Gavriatopoulou M, Garcia-Sanz R, Kastritis E, Morel P, Kyrtsonis MC, Michalis E, Kartasis Z, Leleu X, Palladini G, Tedeschi A, Gika D, Merlini G, Sonneveld P, Dimopoulos MA. BDR in newly diagnosed patients with WM: final analysis of a phase 2 study after a minimum follow-up of 6 years. Blood. 2017 Jan 26;129(4):456-459. doi: 10.1182/blood-2016-09-742411. Epub 2016 Nov 21.
- Derived from this study: PubMed 24004667Dimopoulos MA, Garcia-Sanz R, Gavriatopoulou M, Morel P, Kyrtsonis MC, Michalis E, Kartasis Z, Leleu X, Palladini G, Tedeschi A, Gika D, Merlini G, Kastritis E, Sonneveld P. Primary therapy of Waldenstrom macroglobulinemia (WM) with weekly bortezomib, low-dose dexamethasone, and rituximab (BDR): long-term results of a phase 2 study of the European Myeloma Network (EMN). Blood. 2013 Nov 7;122(19):3276-82. doi: 10.1182/blood-2013-05-503862. Epub 2013 Sep 4.
- Derived from this study: PubMed 22517904Kastritis E, Terpos E, Roussou M, Gavriatopoulou M, Pamboukas C, Boletis I, Marinaki S, Apostolou T, Nikitas N, Gkortzolidis G, Michalis E, Delimpasi S, Dimopoulos MA. A phase 1/2 study of lenalidomide with low-dose oral cyclophosphamide and low-dose dexamethasone (RdC) in AL amyloidosis. Blood. 2012 Jun 7;119(23):5384-90. doi: 10.1182/blood-2011-12-396903. Epub 2012 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meletios A Dimopoulos, MD principal investigator
University of Athens, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide, Dexamethasone and Cyclophosphamide in people with Amyloidosis, run by University of Athens at 1 site in Greece.
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 18 inclusion and 13 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 30 Apr 2021. 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 Greece. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 assess the maximum tolerated dose of lenalidomide and cyclophosphamide and assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis. (time frame: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response). 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 NCT00981708, which also lists 3 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 30 Apr 2021.