Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

NCT00602511 | Completed Phase 3

• 2 other identifiers: NMSG 17/07EudraCT no. 2007-001292-11
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 27

Brief Summary

The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.

Conditions

Multiple Myeloma

Keywords

Melfalan refractory multiple myeloma; Multiple myeloma; Relapsing; Refractory; Thalidomide; Bortezomib; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Progression free survival

Secondary Outcomes (7)

• Response rate

• Response duration

• Time to start of other treatment

• Toxicity

• Quality of life

Study Arms (2)

1

ACTIVE COMPARATOR

Bortezomib - dexamethasone

Drug: Bortezomib

2

EXPERIMENTAL

Thalidomide - dexamethasone

Drug: Thalidomide

Interventions

Bortezomib DRUG

Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity

1

Thalidomide DRUG

Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity

2

Eligibility Criteria

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

You may qualify if:

• Treatment demanding multiple myeloma
• Refractoriness to melphalan
• Acceptance of rules for prevention of pregnancy

You may not qualify if:

• Previous treatment with bortezomib, thalidomide, or lenalidomide
• Sensory neuropathy grade III or neuropathic pain grade II
• Severe concomitant disorder, e.g. other malignancy or severe heart disease
• Transformation to plasma cell leukemia or aggressive lymphoma
• Frequent visits for bortezomib injections not feasible
• Anticipated non-adherence to study protocol
• Pregnancy
• Anticipated non-adherence to rules for prevention of pregnancy
• Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)

Sponsors & Collaborators

• Nordic Myeloma Study Group: lead

Study Sites (27)

Ålborg university Hospital

Aalborg, 9000, Denmark

Location

Århus University Hospital

Aarhus, 8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Ullevål Sykehus

Oslo, 0407, Norway

Location

Diakonhjemmet

Oslo, Norway

Location

Stavanger Universitetssykehus

Stavanger, 4068, Norway

Location

Trondheim University Hospital

Trondheim, N-7006, Norway

Location

Falun Hospital

Falun, 79182, Sweden

Location

Gävle Hospital

Gävle, 80187, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Helsingborg Hospital

Helsingborg, 25187, Sweden

Location

Lidköping Hospital

Lidköping, 53185, Sweden

Location

Lund University Hospital

Lund, 22185, Sweden

Location

Malmö University Hospital

Malmo, 20502, Sweden

Location

Mölndal hospital

Mölndal, 43180, Sweden

Location

Örebro University Hospital

Örebro, 70185, Sweden

Location

Örnsköldsvik Hospital

Örnsköldsvik, 89189, Sweden

Location

Skövde Hospital

Skövde, 54185, Sweden

Location

St Göran Hospital

Stockholm, 11281, Sweden

Location

Sundsvall Hospital

Sundsvall, 85186, Sweden

Location

Uddevalla Hospital

Uddevalla, 45180, Sweden

Location

Norrland University Hospital

Umeå, 90185, Sweden

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Växjö Hospital

Vaxjo, 35185, Sweden

Location

Västerås Hospital

Västerås, 72189, Sweden

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Bortezomib; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martin Hjorth, MD, PhD

  Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 9, 2011

Record last verified: 2011-02

Locations

SE (18); NO (4); DK (5)