Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

NCT00049673 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: MY10CAN-NCIC-JMY10ECOG-NCIC-JMY10CELGENE-CAN-NCIC-MY10CDR0000258158
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 18

Brief Summary

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for 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)

• Overall Survival

  Number of patients died from any cause during the study.

  9 years

Secondary Outcomes (1)

• Disease Progression-free Survival

  9 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.

Drug: prednisone; Drug: thalidomide

Arm II

NO INTERVENTION

Patients undergo observation.

Interventions

prednisone DRUG

Given orally

Arm I

thalidomide DRUG

Given orally

Arm I

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma as evidenced 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 at least 10% plasmacytosis * Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below * Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR * Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis * Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m\^2) within the past 60-100 days * Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma * No evidence of disease progression PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * No prior hereditary hypercoaguable disorder * Granulocyte count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and/or ALT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal * Creatinine no greater than 3 times ULN Cardiovascular * No prior spontaneous deep vein thrombosis within the past 5 years * Catheter-associated thrombus allowed * No uncontrolled hypertension Pulmonary * No prior pulmonary embolism within the past 5 years Other * No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured * No prior gastric ulceration or bleeding within the past 5 years * No prior documented lupus anti-coagulant or anti-phospholipid antibody * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation * Male patients must use effective barrier contraception during and for 1 month after study participation * No avascular necrosis of the hips or shoulders * No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed) * No diabetes with end-organ damage defined as: * Documented diabetic neuropathy * Retinal vascular proliferation requiring treatment * Cardiovascular disease requiring active therapy * Willing to complete quality of life questionnaires * Employment does not prohibit the use of sedatives * No other major medical illness or condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior double autologous or allogeneic hematopoietic stem cell transplantation * No prior thalidomide Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent anti-cancer 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
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (18)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, AIB 3V6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

• Stewart AK, Trudel S, Bahlis NJ, White D, Sabry W, Belch A, Reiman T, Roy J, Shustik C, Kovacs MJ, Rubinger M, Cantin G, Song K, Tompkins KA, Marcellus DC, Lacy MQ, Sussman J, Reece D, Brundage M, Harnett EL, Shepherd L, Chapman JA, Meyer RM. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial. Blood. 2013 Feb 28;121(9):1517-23. doi: 10.1182/blood-2012-09-451872. Epub 2013 Jan 7.

  PMID: 23297129 RESULT

• Kovacs MJ, Davies GA, Chapman JA, Bahlis N, Voralia M, Roy J, Kouroukis CT, Chen C, Belch A, Reece D, Zhu L, Meyer RM, Shepherd L, Stewart KA. Thalidomide-prednisone maintenance following autologous stem cell transplant for multiple myeloma: effect on thrombin generation and procoagulant markers in NCIC CTG MY.10. Br J Haematol. 2015 Feb;168(4):511-7. doi: 10.1111/bjh.13176. Epub 2014 Oct 10.

  PMID: 25302852 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Prednisone; Thalidomide

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)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Canadian Cancer Trials Group

jdancey@ctg.queensu.ca

613-533-6340

Study Officials

• A. Keith Stewart, MD

  Mayo Clinic

  STUDY CHAIR

• Martha Q. Lacy, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: October 15, 2002
• Primary Completion: October 19, 2011
• Study Completion: September 19, 2013
• Last Updated: September 13, 2023
• Results First Posted: October 5, 2020

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (18)