Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older



Status:Recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:8/9/2018
Start Date:June 24, 2010
End Date:March 2020
Contact:Michele Donato, MD
Email:Michele.Donato@HackensackMeridian.org
Phone:201-996-5900

Use our guide to learn which trials are right for you!

(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.

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 less than 12 months since initiation of
systemic therapy

- Age ≥60 years at time of transplantation

- KPS 70-100%

- Recovery from complications of prior therapy

Exclusion Criteria:

- Diagnosis other than multiple myeloma

- Chemotherapy or radiotherapy within 8 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
We found this trial at
2
sites
3970 Reservoir Rd NW E501
Washington, District of Columbia 20007
(202) 687-2110
Principal Investigator: Pashna Munshi, MD
Phone: 202-687-4773
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Georgetown Lombardi Comprehensive Cancer Center, part...
?
mi
from
Washington,
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Michele Donato, MD
Phone: 551-996-5828
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials