Neoplasms

Blood and Lymph Conditions

All Conditions

Nutritional and Metabolic Diseases

Immune System Diseases

Rare Diseases

Leukemia

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Proteostasis Deficiencies

Metabolic Diseases

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Paraproteinemias

AL Amyloidosis

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Amino Acids

Thalidomide

Dexamethasone

Melphalan

Lenalidomide

Dexamethasone acetate

BB 1101

Immunosuppressive Agents

Mechlorethamine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Phenylalanine

Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment).

Lenalidomide is a a derivative of thalidomide.

Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle.

Melphalan is a phenylalanine derivative of mechlorethamine.

Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle

Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle

Stanley L Schrier, MD

This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.

The study will evaluate the 3-drug combination of lenalidomide; melphalan; and dexamethasone (MDR) as the absence of disease progression or toxicity, patients will complete nine 28-day cycles of MDR therapy, with the option of continuing treatment with lenalidomide as single-agent. Patients received up to nine cycles of treatment, with the option to continue on lenalidomide as a single agent if they responded to treatment.

A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs \[dFLC\] \< 40 mg/L); or partial response (dFLC decrease \> 50%).

Participants alive 12 months after starting MDR treatment.

Assessed as the median value for EFS 12 months after starting MDR treatment

Assessed as the median value for the time from first partial response until progression; death; or last follow-up.

Celgene Corporation

Stanford University

Professor of Medicine

The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.

Lenalidomide, Melphalan and Dexamethasone (MDR)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

ECOG PS 1

ECOG PS 2

ECOG PS 3

ECOG Performance Status. PS 0 = Fully active, able to carry on all pre-disease performance without restriction.

PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

PS 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. PS 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours..

ECOG Performance Status (PS)

Kappa free light chain (%)

Lambda free light chain (%)

Hematologic disease burden

Lenalidomide-naïve adults with biopsy-proven amyloidosis manifested as measurable disease, ECOG ≤ 3

Brenda Hann, RN, MBA, CCRC

Complete Response (CR)

Very good Partial Response (VGPR)

Partial Response (PR)

No Response (NR)

Response not evaluable

The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.

Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.

Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.

Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.

Subjects completing at least one full cycle of study treatment

Hematologic Response Rate

Overall Survival (OS)

Event-free Survival (EFS)

All participants who achieved at least a partial response (9 subjects were not included due to not having any response)

Duration of Response

Enrollment and Pre-treatment

On-treatment

Spots Global Cancer Trial Database for A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial