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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2015 by Hackensack University Medical Center

Sponsor:

Information provided by (Responsible Party):

Hackensack University Medical Center

ClinicalTrials.gov Identifier:

NCT01241708

First received: November 15, 2010

Last updated: August 21, 2015

Last verified: August 2015

History of Changes

Purpose

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	Intervention	Phase
Multiple Myeloma Auto Stem Cell Transplant	Drug: Bortezomib	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Melphalan Bortezomib

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	110
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Intervention Details:

Bortezomib 1.6mg/m2 on day -4 and day -1

Other Name: Velcade

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241708

Contacts


Contact: Michele Donato, MD		MDonato@humed.com

Locations


United States, New Jersey
John Theurer Cancer Center @ Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Emily Brown, RN 551-996-3923 EmilyBrown@hackensackUMC.org
Contact: Ann Marie Maguire, RN 551-336-8213 AMaguire@hackensackUMC.org
Principal Investigator: Michele Donato, MD

Sponsors and Collaborators

Hackensack University Medical Center

Investigators


Principal Investigator:	Michele Donato, MD	John Theurer Cancer Center at Hackensack University Medical Center

More Information


Responsible Party:	Hackensack University Medical Center
ClinicalTrials.gov Identifier:	NCT01241708 History of Changes
Obsolete Identifiers:	NCT01374958
Other Study ID Numbers:	Pro00001295
Study First Received:	November 15, 2010
Last Updated:	August 21, 2015
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 28, 2016

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