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MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256776
Recruitment Status : Terminated
First Posted : November 22, 2005
Last Update Posted : December 22, 2020
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Celgene Corporation
Information provided by (Responsible Party):
European Group for Blood and Marrow Transplantation

Brief Summary:

This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation.

Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.

Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Velcade (Bortezomib) Drug: Thalidomide Drug: Dexamethasone Phase 3

Detailed Description:

Primary Objectives:

* Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation.

Secondary Objectives:

* Compare the treatment groups for: overall survival; response rate (complete & partial & minimal) using standard criteria and treatment related complications.

Study design and methodology:

This is a prospective, randomized, parallel-group, open-label phase III, on an intention to treat, multicenter study. The main endpoint is time-to-failure (TTP=time to progression). The power is based on an initial assumption of a median TTP of 1.5 years in the experimental (Velcade) group and 1 year in the control group. The design of the study is group sequential. There will be 4 interim analyses and one final analysis. The study is designed to have a priori 90% power to detect the clinically relevant difference at completion of the study at 0.025 level. Patients with multiple myeloma whose disease has either progressed or relapsed at least one year after one or two autologous transplantations will be enrolled. Prior to random assignment, subjects will be stratified on center and number of autologous transplants.Subjects will be randomly assigned to treatment in a 1: 1 allocation within each stratum to Velcade plus Thalidomide plus Dexamethasone (VTD) or Thalidomide plus Dexamethasone. Velcade 1.3 mg/m2 will be given as an i.v. bolus on Days 1, 4, 8 and 11 followed by a 10-day rest period (Days 12 to 21) for 8 cycles (6 months) and then on Days 1, 8, 15, and 22 followed by a 20-day rest period (Days 23 to 42) for 4 cycles (6 months). In both arms, Thalidomide will be given at 200 mg/day per os for one year and Dexamethasone 40 mg/day per os four days every three weeks for one year.Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity, or up to a total of 12 cycles of Velcade except for those subjects who have a continuing decrease in the levels of paraprotein after 12 cycles. These subjects may continue for as long as treatment is tolerated, and they continue to respond. If a subject has a CR, then treatment should continue at least 2 cycles after the objective response is confirmed. For subjects with a PR or stable disease, treatment may continue after a maximum objective response is confirmed unless the subject experiences unacceptable treatment-related toxicity or the subject has completed 12 cycles of treatment. Disease assessment will occur at the start of each cycle. If a subject discontinues treatment without disease progression, disease assessment will be performed every 3 weeks for 48-weeks from the start of the first dose of study entry drug. Subjects who have not progressed at the end of 48-week follow up period will be assessed every 6 weeks until disease progression is documented

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation
Study Start Date : July 2005
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Thal + Dex + Velcade Drug: Velcade (Bortezomib)
Drug: Thalidomide
Drug: Dexamethasone
Active Comparator: Thal + Dex
Standard treatment
Drug: Thalidomide
Drug: Dexamethasone

Primary Outcome Measures :
  1. Time to progression, the interval between the date of randomization and date of disease progression (death without progression is a competing risk) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival (interval between date of randomization and death from any cause [ Time Frame: 1 year ]
  2. Response rate (proportion of subjects who achieve complete, partial, or minimal response) [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female ≥18 years-of-age
  • Multiple myeloma with evaluable disease
  • Relapsing or having a progressive disease
  • Karnofsky performance status > 50 %
  • Life expectancy of at least 3 months
  • Female of child-bearing potential must have a method of birth control and a negative serum or urine beta--human chorionic gonadotropin (β-HCG) pregnancy test at screening and all through the study
  • Male must use contraception
  • Voluntary written informed consent

Exclusion Criteria:

  • Non-secretory multiple myeloma
  • Platelet count < 40,000 X 10^9/L
  • Absolute neutrophil count <1.0 X 10^9/L
  • Creatinine clearance <30 mL/minute
  • Peripheral neuropathy >= Grade 2
  • Seropositive for HIV, or active hepatitis A, B or C infection
  • Pregnant or breastfeeding female
  • Patient has hypersensitivity to bortezomib, boron or mannitol
  • Other investigational drugs
  • Serious medical or psychiatric illness
  • Previous or concurrent malignancies at other sites
  • Poorly controlled hypertension, uncontrolled or severe cardiovascular disease or uncontrolled diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256776

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Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Celgene Corporation
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Principal Investigator: Laurent Garderet, MD Hôpial Saint Antoine, Paris, France - <>
Additional Information:
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Responsible Party: European Group for Blood and Marrow Transplantation Identifier: NCT00256776    
Other Study ID Numbers: EudraCT: 2005-001628-35
EBMT-CLWP: 42206611
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Keywords provided by European Group for Blood and Marrow Transplantation:
Multiple Myeloma
Autologous transplantation
Disease progress
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors