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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

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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 CenterHackensack, New Jersey  07601