Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma

Hackensack Meridian Health148 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Multiple Myeloma Auto Stem Cell Transplant

Interventions

BortezomibDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

John Theurer Cancer Center @ Hackensack University Medical Center

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

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.

Progression-free survival of participants that received tandem transplants on study

Time frame: 3 years

Secondary Outcomes

To Determine the Response Rate of Patients With Multiple Myeloma Treated With High-dose Melphalan or High-dose Melphalan in Combination With Bortezomib Given in Tandem Transplants.

Overall response rate of participants after completing tandem transplant. Overall Response rate defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.

Time frame: 3 years

To Determine the Overall Survival of Patients With Multiple Myeloma Treated With High-dose Melphalan or High-dose Melphalan in Combination With Bortezomib Given in Tandem Transplants.

Survival rate of participants after completion of tandem transplant

Time frame: 3 years

Data from ClinicalTrials.gov

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