Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Melphalan

Lenalidomide

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

A1 Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)

A2 Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years

Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)

Lenalidomide, Dexamethasone

Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years

Lenalidomide, Dexamethasone, PBSCT

Christian Straka

In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation.

Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

To compare the efficacy of both treatment regimens with regard to progression-free survival.

To assess the safety and overall survival of both treatment regimens.

To investigate other efficacy parameters of both treatment regimens

ClinAssess GmbH

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Antirheumatic Agents

Cyclophosphamide

Prednisone

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Induction treatment with oral Lenalidomide and low dose dexamethasone followed by maintenance therapy with Lenalidomide alone or Lenalidomide and Prednisone

Induction treatment with oral Lenalidomide, Prednisone and Melphalan followed by maintenance therapy with Lenalidomide alone or Lenalidomide and Prednisone

Induction treatment with oral Lenalidomide, Cyclophosphamide and Prednisone for followed by maintenance therapy with Lenalidomide alone or Lenalidomide and Prednisone.

Induction: 9 courses every 28 days - oral Lenalidomide for 21 days followed by a 7 days rest period; oral Melphalan for 4 days, followed by a 24 days rest period \[different doses according to the age of patients (65-75 or \>75 years old);oral Prednisone for 4 days followed by a 24 day rest period.

Maintenance: ARM A1, B1 and C1 - oral Lenalidomide on day 1-21 followed by a 7 days rest period.

ARM A2,B2 and C2:oral Lenalidomide on day 1-21 followed by a 7 days rest period and oral Prednisone every other day.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).

Melphalan, Prednisone, Lenalidomide

Induction: 9 cycles every 28 days:Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28;Cyclophosphamide will be given orally at the dose of 50 mg /day for 21 days followed by a 7 day rest period (days 1 to 28) in patients 65-75 years old and 50 mg every other day (days 1 to 20 followed by a 8 days rest period \[day 21 to 28\]) in patients older than 75 years.Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).

Cyclophosphamide, Prednisone, Lenalidomide

Induction: 9 course every 28 days-Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28); Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15 and 22 every 28 days in patients 65-75 years old and at the dose of 20 mg on days 1,8,15 and 22 every 28 days in patients older than 75 years. Maintenance:After 2-3 months from the completion of the last induction cycle, patients will start maintenance therapy according to physician willing and general dose-reduction rules.ARM A1, B1 and C1:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period. ARM A2, B2 and C2:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period; Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28) Each cycle will be repeated every 28 days, until any sign of disease progression (PD).

Lenalidomide, dexamethasone

Mario Boccadoro, MD

This is a multicenter, randomized, controlled, 3 arm parallel group study designed to evaluate the efficacy and safety of three all-oral combinations: lenalidomide with dexamethasone (Rd) in comparison with lenalidomide in association with MP (MPR) and lenalidomide in association with cyclophosphamide - prednisone (CPR) in newly diagnosed symptomatic MM patients. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study.

This is an intergroup multicenter, randomized, open label study designed to compare the efficacy and safety of Rd with MPR and CPR in newly diagnosed symptomatic MM patients who are 65 years of age or older. Potential study subjects will sign an informed consent prior to undergoing any study related procedure.

This study consists of 3 phases for each study subject: Pre-treatment, Treatment and Follow up.Pre-treatment period: patients will undergo screening for protocol eligibility within 28 days (4weeks) prior to randomization.

Subjects who meet all the inclusion criteria will be randomized based on a computer-generated randomization schedule prepared by the Coordinating Centre. The first randomization will occur for the induction treatment: Arm A (Rd) or B (MPR) or C (CPR). Within each arm patients will be then randomized for the maintenance treatment(lenalidomide or lenalidomide and prednisone): Arms A1 (R) and A2 (RP); Arms B1 (R) and B2 (RP); Arms C1 (R) and C2 (RP). Randomization will be concealed until the end of the induction period for the maintenance treatment. Patients will be stratified at randomization according to the International Staging System (5) and age (\< 75 years vs \> 75 years).Treatment period includes induction and maintenance. During the induction and maintenance phases, all patients will attend periodic study center visits in order to asses the safety and efficacy of the treatment. This protocol also provides a substudy designed to observe asymptomatic patients excluded to the protocol that in any case could be inserted in the study . The asymptomatic patient is characterized by the absence of end-organ damage or tissue involvement, such as anemia, bone lesions, hypercalcemia, and renal failure, or by other relevant clinical conditions, such as hyperviscosity, amyloidosis, and recurrent infections (CRAB).

Lenalidomide and Dexamethasone Versus Melphalan Prednisone and Lenalidomide Versus Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients

A Phase 3, Intergroup Multicentre, Randomized, Controlled 3 Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Dexamethasone (RD) Versus Melphalan, Prednisone and Lenalidomide (MPR) Versus Cyclophosphamide, Prednisone and Lenalidomide (CPR) in Newly Diagnosed Elderly Multiple Myeloma Subjects

Fondazione EMN Italy Onlus

Leukemia

Leukemia, Plasma Cell

Plasma Cell Leukemia

Bortezomib

Enrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle.

Patients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study.

Pellegrino Musto, MD

This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).

The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.

Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia

Number of eligible patients reaching stem cell transplantation procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma	NCT01090089	Multiple Myelom...	Lenalidomide, D... Lenalidomide, D...	60 Years - 75 Years	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Lenalidomide and Dexamethasone Versus Melphalan Prednisone and Lenalidomide Versus Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients	NCT01093196	Multiple Myelom...	Melphalan, Pred... Cyclophosphamid... Lenalidomide, d...	18 Years -	Fondazione EMN Italy Onlus
Lenalidomide and Dexamethasone Versus Melphalan Prednisone and Lenalidomide Versus Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients	NCT01093196	Multiple Myelom...	Melphalan, Pred... Cyclophosphamid... Lenalidomide, d...	18 Years -	Fondazione EMN Italy Onlus
Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia	NCT01553357	Primary Plasma ...	Lenalidomide, d...	18 Years -	IRCCS Centro di Riferimento Oncologico della Basilicata
Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma	NCT01090089	Multiple Myelom...	Lenalidomide, D... Lenalidomide, D...	60 Years - 75 Years	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia	NCT01553357	Primary Plasma ...	Lenalidomide, d...	18 Years -	IRCCS Centro di Riferimento Oncologico della Basilicata

Spots Global Cancer Trial Database for lenalidomide, dexamethasone