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Sponsored by: |
Nantes University Hospital |
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Information provided by: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT00621400 |
Amyloidosis results from tissue deposition of amyloid protein, composed mainly by the fragments of monoclonal immunoglobulin heavy chains or light chains. Accumulation of amyloid protein progressively disrupts normal tissue structure and ultimately leads to organ failure, most frequently in the kidneys, heart, liver and peripheral nervous system. A recently completed French prospective randomized trial, in patients presenting with newly AL-amyloidosis, compared two treatment regimens at the time of diagnosis: Melphalan-dexamethasone (conventional oral treatment), versus high dose of Melphalan followed by autologous stem cell transplantation (ASCT) (1). High-dose therapy was not associated with a better outcome. Melphalan-dex given monthly can be considered as the current standard of care, with a median survival of 56 months. The use of a combination of lenalidomide and dexamethasone has already been tested in patients with AL-amyloidosis (2). The initial dose of lenalidomide at 25 mg/day was poorly tolerated. However, a 15 mg/day dose regimen was well tolerated and effective, with an overall hematologic response rate of 67%. Hematologic responses were associated with clinical responses. Dispenzieri et al confirmed that the combination of Lenalidomide + dexamethasone achieved a 75% hematologic response rate, with a 42% organ response, and a median follow-up of 17 months in patients still receiving treatment (2006). These authors also recommended a lower dose of 15mg/day. The rationale for the present investigation is that addition of lenalidomide to the current standard of care (Melphalan-dexamethasone) might improve the hematologic response rate and the organ response rates both associated with a prolonged survival in patients with AL-amyloidosis. As the toxicity of the combination of M-dex + lenalidomide is unknown in patients with AL-amyloidosis, the dose of lenalidomide will start from the lowest one available, i.e., 5 mg/day and increased from 5 to 5 mg up to a maximum dose of 15 mg in combination with M-dex in 3 consecutive cohorts of patients, according to toxicity. When the optimal dose of lenalidomide will be defined, 9 additional patients will be included in the trial at the recommended dose-level to assess the feasibility of the combination M-dex-lenalidomide.
Condition | Intervention | Phase |
---|---|---|
Amyloidosis |
Drug: Lenalidomide Drug: Melphalan Drug: Dexamethasone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Combination With Melphalan and Dexamethasone in Subjects With Newly-Diagnosed Light-Chain (AL)-Amyloidosis |
Estimated Enrollment: | 42 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function defined as
Exclusion Criteria:
Contact: Philippe Moreau, MD | philippe.moreau@chu-nantes.fr |
France | |
CHU de Nantes | Recruiting |
Nantes, France, 44093 | |
Contact: Philippe Moreau, MD | |
CHU de Limoges | Recruiting |
Limoges, France, 87042 | |
Contact: Arnaud Jaccard, MD | |
Hôpital Saint-Louis | Not yet recruiting |
Paris, France, 75475 | |
Contact: Jean-Paul Fermand, MD | |
Hôpital Pitié Salpetrière | Not yet recruiting |
Paris, France, 75651 | |
Contact: Véronqiue Leblond, MD | |
CHU de Rennes | Not yet recruiting |
Rennes, France, 35203 | |
Contact: Bernard Grosbois, MD | |
CHRU deTours | Not yet recruiting |
Tours, France, 37044 | |
Contact: Lofti Benboubker, MD | |
Hôpital necker | Not yet recruiting |
Paris, France, 75743 | |
Contact: Olivier Hermine, MD | |
CHU de Toulouse | Not yet recruiting |
Toulouse, France, 31059 | |
Contact: Michel Attal, MD | |
CHRU de Lille | Not yet recruiting |
Lille, France, 59037 | |
Contact: Thierry Facon, MD | |
CHRU d'Amiens | Not yet recruiting |
Amiens, France, 80054 | |
Contact: Bruno Royer, MD | |
CHU de Poitiers | Not yet recruiting |
Poitiers, France, 86021 | |
Contact: franck Bridou, MD | |
Hôpitaux Civils de Lyon | Not yet recruiting |
Pierre-Bénite, France, 69495 | |
Contact: Catherine Traullé, MD |
Responsible Party: | Cellule Promotion Recherche Clinique ( Anne Omnes ) |
Study ID Numbers: | BRD 07/7-G, EudraCT 2007-004739-43 |
Study First Received: | February 12, 2008 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00621400 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
newly-diagnosed light-chain (AL)-amyloidosis |
Anti-Inflammatory Agents Dexamethasone Melphalan Metabolic Diseases Immunologic Factors Antineoplastic Agents, Hormonal Hormone Antagonists Lenalidomide Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Immunosuppressive Agents Glucocorticoids Hormones Amyloidosis Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Alkylating Agents Metabolic Disorder Dexamethasone acetate |
Dexamethasone Anti-Inflammatory Agents Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Alkylating Agents Dexamethasone acetate |
Metabolic Diseases Antineoplastic Agents, Hormonal Lenalidomide Gastrointestinal Agents Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Amyloidosis Autonomic Agents Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Central Nervous System Agents |