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

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: Melphalan Drug: Bortezomib	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	(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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Melphalan Melphalan hydrochloride Bortezomib

U.S. FDA Resources

Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:

To compare the progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib. [ 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the response rate, overall survival and toxicity of high-dose melphalan versus high-dose melphalan and bortezomib [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	398
Study Start Date:	June 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Treatment 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).	Drug: 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 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).
Experimental: 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.	Drug: Bortezomib 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.

Arms

Assigned Interventions

Active Comparator: Treatment 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).

Drug: 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 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).

Experimental: 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.

Drug: Bortezomib

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453088

Contacts

Contact: Michele Donato, MD	201-996-5900	MDonato@humed.com
Contact: Marie Del Favero, RN	201-996-5828	MDelFavero@humed.com

Locations

United States, New Jersey
Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Michele Donato, MD

Sponsors and Collaborators

Hackensack University Medical Center

Investigators

Principal Investigator:

Michele Donato, MD

John Theurer Cancer Center at Hackensack University Medical Center

More Information

No publications provided

Responsible Party:	Hackensack University Medical Center
ClinicalTrials.gov Identifier:	NCT01453088 History of Changes
Other Study ID Numbers:	PRO# 1307
Study First Received:	June 30, 2011
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hackensack University Medical Center:

multiple myeloma
transplant

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

Melphalan
Bortezomib
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013