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

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
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Drug: Bortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1
Other Name: Velcade
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- 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 ]
- 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 ]

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

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
Contact: Michele Donato, MD | 551-996-5900 | Michele.Donato@HackensackMeridian.org |
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 |
Principal Investigator: | Michele Donato, MD | John Theurer Cancer Center at Hackensack University Medical Center |
Publications:
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 |