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

• Sponsor: Hackensack Meridian Health (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01241708
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 148.8
• Patients Per Site Per Month: 1

Study Details

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

• Study Type: Interventional
• 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: Apr 8, 2010
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

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 Names: Velcade

Outcome Measures

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. [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. [lifetime]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Theurer Cancer Center @ Hackensack University Medical Center	Hackensack	New Jersey	United States	07601

Sponsors and Collaborators

• Hackensack Meridian Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Hackensack Meridian Health
• ClinicalTrials.gov Identifier: NCT01241708
• Other Study ID Numbers: Pro00001295; NCT01374958
• First Posted: Nov 16, 2010
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Bortezomib

Study Results

No Results Posted as of Aug 26, 2021