Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)

NCT00981708 | Completed Phase 1

• 1 other identifier: RV-178
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyloidosis

Keywords

Amyloidosis; lenalidomide; newly diagnosed; relapsed; primary systemic AL amyloidosis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Monthly for toxicity and every 3-6 months for organ response

Study Arms (1)

Treatment

EXPERIMENTAL

Lenalidomide, Dexamethasone and cyclophosphamide

Drug: Lenalidomide, Dexamethasone and Cyclophosphamide

Interventions

Lenalidomide, Dexamethasone and Cyclophosphamide DRUG

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)

Also known as: Revlimid, Endoxan, Dexamethasone

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Athens: lead
• Hellenic Cooperative Oncology Group: collaborator

Study Sites (1)

Alexandra Hospital , Department of Clinical Therapeutics

Athens, Attica, 115 28, Greece

Location

Related Publications (3)

• 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.

  PMID: 27872060 DERIVED

• Dimopoulos 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 DERIVED

• Kastritis 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 DERIVED

MeSH Terms

Conditions

Amyloidosis; Recurrence; Immunoglobulin Light-chain Amyloidosis

Interventions

Lenalidomide; Dexamethasone; Cyclophosphamide

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Meletios A Dimopoulos, MD

  University of Athens, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 19, 2009
• First Posted: September 22, 2009
• Study Start: February 1, 2008
• Primary Completion: January 11, 2011
• Study Completion: January 11, 2016
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

GR (1)