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

Hackensack Meridian Health

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma; Auto Stem Cell Transplant

Treatments: Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT01241708

Pro00001295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

Tandem Transplantation with Melphalan and Bortezomib

Experimental group

Description:

Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma

Treatment:

Drug: Bortezomib