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 : Active, not recruiting

First Posted : November 16, 2010

Last Update Posted : August 26, 2021

Sponsor:

Information provided by (Responsible Party):

Hackensack Meridian Health

Study Description

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)
Actual Enrollment :	146 participants
Allocation:	N/A
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 :	September 2022
Estimated Study Completion Date :	September 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Melphalan Melphalan hydrochloride Bortezomib

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Arms and Interventions

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

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 ]

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
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

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

Locations

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United States, New Jersey
John Theurer Cancer Center @ Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601

Sponsors and Collaborators

Hackensack Meridian Health

Investigators

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

More Information

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Responsible Party:	Hackensack Meridian Health
ClinicalTrials.gov Identifier:	NCT01241708
Obsolete Identifiers:	NCT01374958
Other Study ID Numbers:	Pro00001295
First Posted:	November 16, 2010 Key Record Dates
Last Update Posted:	August 26, 2021
Last Verified:	August 2021

Additional relevant MeSH terms:

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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 Antineoplastic Agents

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