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


Phase 3
18 Years
64 Years
Open (Enrolling)
Both
Multiple Myeloma, Auto Stem Cell Transplant

Thank you

Trial Information

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


Inclusion Criteria:



- Confirmed diagnosis of multiple myeloma 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 21 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

- Uncontrolled CNS metastases

- Known amyloid deposition in heart

- Organ dysfunction

- LVEF <40% or cardiac failure not responsive to therapy

- FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Michele Donato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

John Theurer Cancer Center at Hackensack University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

Pro00001295

NCT ID:

NCT01241708

Start Date:

April 2010

Completion Date:

Related Keywords:

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

Name

Location

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