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Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma ((Mel/MelVel))

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ClinicalTrials.gov Identifier: NCT01241708
Recruitment Status : Recruiting
First Posted : November 16, 2010
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center

Study Description
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Brief Summary:
High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Auto Stem Cell Transplant Drug: Bortezomib Phase 3

Detailed Description:

Many patients with multiple myeloma receive 2 stem cell transplantations within a few months of each other as part of their treatment. Usually the drug Melphalan is used for both transplants.

Bortezomib is a drug that is used for treating multiple myeloma and has been used in combination with melphalan for stem cell transplantation for patients with multiple myeloma.

The purpose of this trial is to study the effects of doing 2 transplants, first using melphalan and second using melphalan and bortezomib. The trial is aiming to find out if adding the Bortezomib to the second transplant will increase the chances of staying in remission longer.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Actual Study Start Date : April 8, 2010
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tandem Transplantation with Melphalan and Bortezomib
Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma
 Drug: Bortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1
Other Name: Velcade


Outcome Measures
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Primary Outcome Measures :
  1. To determine the progression-free survival of patients with multiple myeloma treated with tandem cycles of high-dose melphalan followed by high-dose melphalan in combination with bortezomib with autologous HSC transplantation. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To determine the response rate, overall survival, and regimen-related toxicities of patients with multiple myeloma treated with high-dose melphalan or high-dose melphalan in combination with bortezomib given in tandem transplants. [ Time Frame: lifetime ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Changed from: Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or ISS stage I, II or III, less than 12 months since initiation of systemic therapy
  • ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants
  • Age: 18-75 years at time of transplantation
  • KPS 70-100%
  • Recovery from complications of prior therapies
  • Gender: There is no gender restriction

Exclusion Criteria:

  • Diagnosis other than multiple myeloma
  • Chemotherapy or radiotherapy within 8 days of initiating treatment in this study
  • Prior autologous or allogeneic transplantation (except as enrolled into this study)
  • Uncontrolled bacterial, viral, fungal or parasitic infections
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01241708


Contacts
Contact: Michele Donato, MD 551-996-5900 Michele.Donato@HackensackMeridian.org

Locations
United States, New Jersey
John Theurer Cancer Center @ Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Marifiel Vendivil, RN    551-996-5828    Marifiel.Vendivil@HackensackMeridian.org   
Contact: Andrea Ortega, RN    551-336-3923    Andrea.Ortega@HackensackMeridian.org   
Principal Investigator: Michele Donato, MD         
Sub-Investigator: Scott Rowley, MD         
Sub-Investigator: David Vesole, MD, PhD         
Sub-Investigator: David Siegel, MD, PhD         
Sub-Investigator: Alan Skarbnik, MD         
Sub-Investigator: Michele Simone, APN         
Sub-Investigator: Phyllis McKiernan, APN         
Sub-Investigator: Melissa Baker, APN         
Sub-Investigator: Michele Boonstra, APN         
Sub-Investigator: Mary DiLorenzo, APN         
Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: Michele Donato, MD John Theurer Cancer Center at Hackensack University Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Cleveland, WS: Robust locally-weighted regression and smoothing scatterplots. J. Am Stat Assoc. 1979; 74: 829-836
Cox, DR. Regression models and life tables (with discussion). J R Stat Soc B.1972; 34:187-220.
Fossella F. Docetaxel + Cisplatin (DC) and Docetaxel + Carboplatin (DCb) vs Vinorelbine + Cisplatin (VC) in chemotherapy-naïve patients with advanced and metastatic non-small cell lung cancer (NSCLC): Results of a multicenter, randomized phase III study. European Journal of Cancer, European Cancer Conference, ECCO 11, 2001; Lisbon, Portugal. 37(suppl 6):S154. Abstract 562
Hollmig K, Stover J, Talamo G, et al. Addition of bortezomib (Velcade™) to high dose melphalan (VelMel) as an effective conditioning regimen with autologous stem cell support in multiple myeloma (MM). Blood 2004;104:266a
Papandreou C, Daliani D, Millikan RE, Tu S, Pagliaro L, Adam J. Phase I Study of Intravenous (I.V.) Proteasome Inhibitor PS-341 in Patients (Pts) with Advanced Malignancies. Proc Am Soc Clin Oncol, 2001. Abstract 340
Pineda-Roman M, Fox MH, Hollmig KA, et al. Retrospective analysis of fractionated high-dose melphalan (F-Mel) and bortezomib-thalidomide-dexamethasone (VTD) with autotransplant (AT) support for advanced and refractory multiple myeloma (AR-MM). Blood 2006;108:884a
Rowley SD, Siegel, D, Donato ML,et al. Combination melphalan and bortezomib conditioning with autologous hematopoeitic stem cell support in patients with advanced multiple myeloma. A phase I/II study. Blood 2009;114:499

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT01241708     History of Changes
Obsolete Identifiers: NCT01374958
Other Study ID Numbers: Pro00001295
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
 Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Melphalan
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs