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(PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older


Phase 2
65 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

(PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older


In this study the investigators are comparing this standard regimen to the newly established
regimen of melphalan and bortezomib.

Conditioning Regimens:

Treatment arm A Melphalan is administered at a dose of 200mg/m2 by rapid intravenous
infusion via a central or peripheral vein over 30 minutes to one hour.

Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.

Dosing will be based on body surface area calculated using actual body weight

Stem cell infusion:

Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of
melphalan. The infusion of peripheral blood stem cells will be done in accordance with the
Blood and Marrow Transplant program standard operating procedures.

Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day
starting on day+3 then daily starting on day 9 until engraftment (at least).

Treatment arm B

Bortezomib:

Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral
vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at
least 20 hrs after the start of the melphalan infusion on day -1.

Dosing will be based on actual body weight. Dexamethasone is administered at a dose of 20 mg
IV prior to each bortezomib infusion.

Melphalan:

Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central
or peripheral vein over 30 minutes to one hour.

Melphalan will be given as a single dose (not split over 2 or more days) and given of day-2.

Dosing will be based body surface area calculated using actual body weight

Stem cell infusion:

Stem cell infusion will occur on day 0 and will be at least 18 hours after the infusion of
the bortezomib. The infusion of peripheral blood stem cells will be done in accordance with
the Blood and Marrow Transplant program standard operating procedures.

Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day
starting on day+3 then daily starting on day 9 until engraftment (at least).

Post-transplant Supportive Care will be administered in accordance to the Blood and Marrow
Transplant program standard operating procedures.


Inclusion Criteria:



- Confirmed diagnosis of multiple myeloma ISS stage I, II or III less than 12 months
since initiation of systemic therapy

- Age 65 years or older at time of transplantation

- KPS 70-100%

- Recovery from complications of prior therapy

Exclusion Criteria:

- Diagnosis other than multiple myeloma

- Chemotherapy or radiotherapy within 21 days of initiating treatment in this study

- Prior dose-intense therapy within 56 days of initiating treatment in 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 < 40% of predicted and/or receiving supplementary continuous oxygen

- Evidence of hepatic synthetic dysfunction or total bilirubin > 2x or AST > 3x ULN

- Measured creatinine < 20ml/min

- Sensory peripheral neuropathy grade 4 within 14 days of enrollment

- Karnofsky score < 70%

- Life expectancy limited by other co-morbid illnesses

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib.

Outcome Time Frame:

Participants will be followed post transplant for a minimum of 2 years, and after that may be monitored as part of the study indefinitely

Safety Issue:

Yes

Principal Investigator

Michele Donato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

John Theurer Cancer Center at Hackensack University Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

PRO# 1307

NCT ID:

NCT01453088

Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • transplant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601