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

Multiple Myeloma Clinical Trial

— (Mel/MelVel)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241708
• Other study ID #: Pro00001295
• Status: Completed
• Phase: Phase 3
• Start date: April 8, 2010
• Est. completion date: July 15, 2023

Study information

• Verified date: August 2023
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01374958

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Auto Stem Cell Transplant
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1

Locations

Country	Name	City	State
United States	John Theurer Cancer Center @ Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

References & Publications (62)

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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