Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma

NCT00305812 | Completed Phase 2 DMC

• 4 other identifiers: MY11CAN-NCIC-MY11CELGENE-CAN-NCIC-MY11CDR0000466184
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 14

Brief Summary

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with melphalan may kill more cancer cells. PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicity within first 3 courses of treatment

Secondary Outcomes (7)

• Toxicity

• Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy

• Time to progression

• Overall survival

• Duration of disease-free interval

Interventions

dexamethasone DRUG

lenalidomide DRUG

melphalan DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma by one of the following: * Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells * Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis * Bone marrow \< 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria * Ineligible for stem cell transplantation due to any of the following: * Advanced age * Comorbid illness * Patient preference * Previously untreated disease * Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis * No nonsecretory myeloma PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 months * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 150,000/mm\^3 * Creatinine ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST and/or ALT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment * No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix * No hypersensitivity to thalidomide or its components, including the development of a desquamating rash * No other serious illness or medical condition that would preclude study participation * No history of significant neurologic or psychiatric disorder that would preclude informed consent * No known HIV positivity * No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following: * Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization * Any cardiac disease that increases risk for ventricular arrhythmia * History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following: * Multifocal premature ventricular contractions * Bigeminy * Trigeminy * Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS PRIOR CONCURRENT THERAPY: * No prior chemotherapy or corticosteroids for the treatment of multiple myeloma * Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,\< 120 mg for dexamethasone or \< 792 mg for prednisone) * Prior radiotherapy to single sites for pain control or local plasmacytoma allowed * Prior or concurrent bisphosphonates allowed * At least 28 days since prior investigational anticancer agents or therapy * No concurrent corticosteroids above physiologic replacement doses * Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed * No concurrent filgrastim (G-CSF) on day 1 of course 1 * No other concurrent anticancer therapy * No other concurrent investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (14)

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Algoma District Cancer Program at Sault Area Hospital

Sault Ste. Marie, Ontario, P6A 2C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Humber River Regional Hospital - Weston

Toronto, Ontario, M9N 1N8, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (4)

• White DJ, Paul N, Macdonald DA, Meyer RM, Shepherd LE. Addition of lenalidomide to melphalan in the treatment of newly diagnosed multiple myeloma: the National Cancer Institute of Canada Clinical Trials Group MY.11 trial. Curr Oncol. 2007 Apr;14(2):61-5. doi: 10.3747/co.2007.107.

  PMID: 17576467 BACKGROUND

• White DJ, Bahlis NJ, Marcellus DC, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: the NCIC CTG MY.11 trial. [Abstract] Blood 112 (11): A-2767, 2008.

  RESULT

• White DJ, Kovacs MJ, Belch A, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: toxicity data from the NCIC CTG MY.11 trial. [Abstract] Blood 110 (11): A-189, 2007.

  RESULT

• White DJ, Bahlis NJ, Marcellus DC, Belch A, Stewart AK, Chen C, Kovacs MJ, Macdonald DA, Reece DE, Reiman T, Harnett E, Meyer RM, Chapman JA, Couban S. Lenalidomide plus melphalan without prednisone for previously untreated older patients with multiple myeloma: a phase II trial. Clin Lymphoma Myeloma Leuk. 2013 Feb;13(1):19-24. doi: 10.1016/j.clml.2012.08.009. Epub 2012 Nov 7.

  PMID: 23141150 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Dexamethasone; Lenalidomide; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; 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; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Darrell White, MD

  Nova Scotia Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: March 9, 2006
• Primary Completion: June 30, 2008
• Study Completion: June 30, 2008
• Last Updated: August 4, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)