Clinical trial · Interventional
Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may be an effective treatment for primary systemic amyloidosis. PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with primary systemic amyloidosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CRD
- description
- Lenalidomide 15mg daily (days 1-21) Cyclophosphamide 300 mg/m\^2 (days 1, 8, 15) Dexamethasone 40 mg weekly
- interventionNames
- Drug: cyclophosphamide
- Drug: dexamethasone
- Drug: lenalidomide
Primary outcomes (1)
- measure
- Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
- timeFrame
- Duration on study (up to 3 years)
- description
- Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histochemical diagnosis of AL amyloidosis based on detection of green birefringent material in Congo red-stained tissue specimens by polarizing microscopy * Measurable disease, as defined by one of the following: * Serum monoclonal protein ≥ 1.0 g by serum electrophoresis * Urine monoclonal protein \> 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * Symptomatic organ involvement with amyloid to justify therapy * May include liver involvement, cardiac involvement, renal involvement, grade 1 peripheral neuropathy, or soft tissue involvement * Must have more than skin purpura or carpal tunnel syndrome * No amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as only evidence of disease \- Vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis * No clinically overt multiple myeloma (i.e., monoclonal BMPC \> 30%, bone lesions, or hypercalcemia) PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,000/μL * Platelet count ≥ 75,000/μL * Creatinine \< 3.0 mg/dL * Not pregnant * Negative pregnancy test * Fertile patients must use two acceptable methods of contraception for ≥ 28 days prior to, during, and for ≥ 28 days after completion of study treatment * No nursing during and for ≥ 28 days after completion of study treatment * No blood, semen, or sperm donation during and for ≥ 28 days after completion of study treatment * No malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast * No neuropathy ≥ grade 2, defined as motor neuropathy (symptomatic weakness interfering with function, but not interfering with activities of daily living \[ADL\]) or sensory neuropathy (sensory alteration or paresthesia \[including tingling\], interfering with function, but not interfering with ADL) * No uncontrolled infection * No syncope within the past 30 days * No known hypersensitivity to thalidomide, including desquamating rash with thalidomide in the past * No known seropositivity for HIV * No active hepatitis A, B, or C * No New York Heart Association class III or IV heart disease * No venous thromboembolic event within the past 42 days * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation - Patients intolerant to aspirin may use low molecular weight heparin PRIOR CONCURRENT THERAPY: * No prior lenalidomide * More than 2 weeks since prior and no other concurrent anticancer agents or treatments * More than 4 weeks since prior experimental agents * No other concurrent corticosteroids except chronic steroids (maximum dose 20 mg/day of prednisone equivalent) for disorders other than amyloidosis (e.g., adrenal insufficiency or rheumatoid arthritis)
References
Publications (1)
- RESULTKumar SK, Hayman SR, Buadi FK, Roy V, Lacy MQ, Gertz MA, Allred J, Laumann KM, Bergsagel LP, Dingli D, Mikhael JR, Reeder CB, Stewart AK, Zeldenrust SR, Greipp PR, Lust JA, Fonseca R, Russell SJ, Rajkumar SV, Dispenzieri A. Lenalidomide, cyclophosphamide, and dexamethasone (CRd) for light-chain amyloidosis: long-term results from a phase 2 trial. Blood. 2012 May 24;119(21):4860-7. doi: 10.1182/blood-2012-01-407791. Epub 2012 Apr 13. PMID 22504925