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

Dexamethasone

Lenalidomide

Dexamethasone acetate

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle

Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.

Lenalidomide 15mg

Lenalidomide 25mg

Nikhil C Munshi, M.D.

This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma.

The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous.

This study expects to enroll approximately 80 subjects from participating VA sites across the nation.

The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose.

Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.

Primary Objective:

• Evaluate the frequency of dose reductions in two different lenalidomide dose regimens.

Secondary Objectives:

* Evaluate the efficacy of two different lenalidomide dose regimens in patients with multiple myeloma using the EBMT and IMWG criteria.
* Evaluate the duration of response of 15 mg Lenalidomide and 25 mg of Lenalidomide when used in combination with Low Dose Dexamethasone.
* Evaluate the safety of 15 mg and 25 mg of Lenalidomide regiments when in combination with dexamethasone.
* Explore blood and cellular levels of angiogenic factors, cytokines, and adhesion molecules.

Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma

A Controlled, Parallel-Group, Randomized, Open-Label Study to Evaluate Two Lenalidomide Dose Regimens When Used in Combination With Low Dose Dexamethasone for the Treatment of Subjects With Relapsed Multiple Myeloma

Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone.

SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated.

SAE Grade 5 Death related to AE.

Number of days between the first day of the first cycle to best M-protein response, at least Minimal Response or higher (Partial Response, Very Good Partial Response, near Complete Response, Complete Response).

Celgene Corporation

Kansas City Veteran Affairs Medical Center

VA Pittsburgh Healthcare System

VA Greater Los Angeles Healthcare System

Michael E. DeBakey VA Medical Center

Edward Hines Jr. VA Hospital

Boston VA Research Institute, Inc.

Principal Investigator -- Coordinating site

Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle

Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

M-protein

Nikhil C. Munshi, M.D.

SAE Grade 3

SAE Grade 4

SAE Grade 5

Serious Adverse Events

Duration Until Best Response (at Least MR or Minimal Response)

Overall Study

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphatic Diseases

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antirheumatic Agents

Etoposide

Cyclophosphamide

Carboplatin

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Immunomodulating Agents

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Lenalidomide 25mg/d PO d1-10 Plus Rituximab 375 mg/m2 IV d1, Cyclophosphamide 750mg/m2 IV d2, Doxorubicin 50mg/m2 IV d2, Vincristine 1.4 mg/m2 IV d2, Prednisone 60 mg/m2 PO d2-6 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5\*\[GFR(ml/min)+25\]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3,

Weili Zhao, MD, PhD

Zhong Zheng, MD

Weili ZHAO, MD, PhD

Shu CHENG, MD, PhD

This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients

Lenalidomide Based Immunotherapy in the Treatment of DLBCL

Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma

Ruijin Hospital

Professor

Nutritional and Metabolic Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Proteostasis Deficiencies

Metabolic Diseases

AL Amyloidosis

As single arm study, patients will be treated as follows:

* Lenalidomide : D1\~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
* Dexamethasone : D1\~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted.

Youngil Koh, MD

This phase II clinical trial aimed at influencing the improvement of major organ functions, especially the objective response rate, in Amyloid light-chain amyloidosis involving myocardium.

This study was designed according to the 18F-florbetaben positron emission tomography imaging, which successfully demonstrated a significant reduction in the amount of amyloid in the heart when administered by merging thalidomide and dexamethasone in patients involving myocardium, and reported that this reaction leads to an improvement in cardiac function. Amyloid light-chain amyloidosis patients at age 19 or older with refractory or relapsed who participants should have never been exposed to lenalidomide within 5 years. Planned initial dosage of the current regimen are as follow;

* Lenalidomide : D1\~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
* Dexamethasone : D1\~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted. The investigator is working on a total of 30 patients, the primary endpoint of this study is objective response rate and secondary endpoints are cardiac/renal/hepatic function, 18F-florbetaben positron emission tomography imaging parameter, overall survival period, progression-free survival period, toxicity profile.

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of Lenalidomide

ORR is defined as the percentage of subjects with evidence of a confirmed CR(complete response), VGPR(very good partial response) or PR(partial response)

Change of the cardiac function will be observed with the NTproBNP levels.

Change of the renal function will be observed with the 24h urine protein levels.

Change of the hepatic function will be observed with the alkaline phophatase levels.

Seoul National University Hospital

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma	NCT01380106	Multiple Myelom...	Lenalidomide 15... Lenalidomide 25...	18 Years -	Boston VA Research Institute, Inc.
Lenalidomide Based Immunotherapy in the Treatment of DLBCL	NCT03715296	Diffuse Large B...	Lenalidomide 25...	16 Years - 75 Years	Ruijin Hospital
Frontline Lenalidomide for AL Amyloidosis Involving Myocardium	NCT04298372	Amyloidosis Car...	Lenalidomide 25...	19 Years - 99 Years	Seoul National University Hospital
Lenalidomide Based Immunotherapy in the Treatment of DLBCL	NCT03715296	Diffuse Large B...	Lenalidomide 25...	16 Years - 75 Years	Ruijin Hospital
Frontline Lenalidomide for AL Amyloidosis Involving Myocardium	NCT04298372	Amyloidosis Car...	Lenalidomide 25...	19 Years - 99 Years	Seoul National University Hospital

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