Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

NCT00335348 | Completed Phase 2

• 2 other identifiers: 05/69ACTRN (pending)
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients with who respond to Velcade. The second aim of this study is to see whether treating patients with relapsed multiple myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Relapse; Bortezomib; Dexamethasone; Maintenance

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria

  2 years

Secondary Outcomes (2)

• Time To Progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease.

  2 years

• Overall survival, defined as the time from commencement of treatment to the date of death from any cause.

  2years

Study Arms (1)

Bortezomib and Dexamethasone

EXPERIMENTAL

Drug: Bortezomib; Drug: Dexamethasone

Interventions

Bortezomib DRUG

Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks

Bortezomib and Dexamethasone

Dexamethasone DRUG

Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks

Bortezomib and Dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or \*third line therapy because of PD, defined as a 25% increase in M-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium \>11.5 mg/dL), or relapse from CR.\*Patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies.
• Patient is of a legally consenting age, as defined by local regulations.
• Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• Male patient agrees to use an acceptable method for contraception for the duration of the study.
• Patient has measurable disease
• Patient has a Karnofsky performance status ≥60%.
• Patient has a life-expectancy \>3 months.

You may not qualify if:

• Primary Dexamethasone resistance
• Prior therapy with Bortezomib
• Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol
• Neuropathy \> Grade 2 with pain by NCI-CTCAE criteria

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Related Publications (1)

• Harrison SJ, Quach H, Link E, Feng H, Dean J, Copeman M, Van De Velde H, Schwarer A, Baker B, Spencer A, Catalano J, Campbell P, Augustson B, Romeril K, Prince HM. The addition of dexamethasone to bortezomib for patients with relapsed multiple myeloma improves outcome but ongoing maintenance therapy has minimal benefit. Am J Hematol. 2015 May;90(5):E86-91. doi: 10.1002/ajh.23967. Epub 2015 Feb 27.

  PMID: 25651830 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Bortezomib; Dexamethasone

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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Miles Prince, MD

  Peter MacCallum Cancer Centre, Melbourne, Australia.

  PRINCIPAL INVESTIGATOR

• Simon Harrison, MB, BS., PhD

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 9, 2006
• Study Start: June 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 9, 2013

Record last verified: 2011-08

Locations

AU (1)