Clinical trial · Interventional
Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)
A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis
NCT00981708CI-TRIAL-00051550completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Amyloidosis | Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide, Dexamethasone and Cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Lenalidomide, Dexamethasone and cyclophosphamide
- interventionNames
- Drug: Lenalidomide, Dexamethasone and Cyclophosphamide
Primary outcomes (1)
- 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.
- timeFrame
- At month 2 for assesment of maximum tolerated dose and monthly for hematologic response
- description
- Maximum Tolerated Dose
Secondary outcomes (1)
- measure
- To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis and organ response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age \>=18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Confirmed diagnosis of AL amyloidosis (see appendix 3) 5. Need for treatment in the judgment of their treating physician 6. Evaluable or measurable disease defined by any of the following: * 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 7. ECOG Performance Status (PS) 0, 1, 2 or 3 8. 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. 9. 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.) 10. 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 11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin). Exclusion Criteria: 1. Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis (Appendix 3) 2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 4. 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. 5. Use of any other experimental drug or therapy within 28 days of baseline. 6. Known hypersensitivity to thalidomide. 7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 8. Any prior use of lenalidomide. 9. Concurrent use of other anti-cancer agents or treatments. 10. Known positive for HIV or infectious hepatitis, type A, B or C. 11. \> grade 2 peripheral neuropathy 12. Life expectancy \< 3 months 13. Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or equivalent corticosteroids for concurrent illness or adrenal replacement therapy
References
Publications (3)
- DERIVEDGavriatopoulou 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. PMID 27872060
- DERIVEDDimopoulos 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. PMID 24004667
- DERIVEDKastritis 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. PMID 22517904