Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00916058
First received: June 5, 2009
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.


Condition Intervention Phase
Multiple Myeloma
Drug: Bendamustine
Drug: Melphalan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1 Pilot Study of a Novel Conditioning Regimen of Bendamustine and Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • To determine the safety and toxicity of the bendamustine/melphalan regimen [ Time Frame: 100 days post autologous stem cell transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the maximally tolerated dose of bendamustine in combination with melphalan as an autologous regimen based on dose limiting toxicities. [ Time Frame: 35 days post autologous stem cell transplant ] [ Designated as safety issue: Yes ]
  • Survival, overall and progression free [ Time Frame: 100 days, 1 year, and overall after autologous stem cell transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: March 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose Level 1
Drug: Bendamustine
30 mg/m2 given on day 2 of melphalan
Other Name: Treanda
Drug: Melphalan
70 mg/m2 given 2 and 3 days prior to autologous cell transplant
Other Name: Alkeran
Experimental: 2
Dose Level 2
Drug: Melphalan
70 mg/m2 given 2 and 3 days prior to autologous cell transplant
Other Name: Alkeran
Drug: Bendamustine
60 mg/m2 given on the 2nd day of melphalan
Other Name: Treanda
Experimental: 3
Dose Level 3
Drug: Melphalan
70 mg/m2 given 2 and 3 days prior to autologous cell transplant
Other Name: Alkeran
Drug: Bendamustine
90 mg/m2 given on the 2nd day of melphalan
Other Name: Treanda
Experimental: 4
Dose Level 4
Drug: Melphalan
70 mg/m2 given 2 and 3 days prior to autologous cell transplant
Other Name: Alkeran
Drug: Bendamustine
60 mg/m2 given on the 1st and 2nd day of melphalan
Other Name: Treanda
Experimental: 5
Dose Level 5
Drug: Melphalan
70 mg/m2 given 2 and 3 days prior to autologous cell transplant
Other Name: Alkeran
Drug: Bendamustine
90 mg/m2 given on the 1st day of melphalan and 60 mg/m2 given on the 2nd day of melphalan
Other Name: Treanda

Detailed Description:

Bendamustine (TREANDA™) has been used in clinical trials to treat multiple myeloma. The results from these trials suggest that it may be beneficial in the treatment of multiple myeloma in a different treatment context. Researchers aim to determine if there may be an improved benefit in the context of bone marrow transplant. This initial clinical trial is intended to help determine how safe it is to use bendamustine as a conditioning regimen for bone marrow transplant, and to look for any initial evidence of benefit.

Bendamustine (TREANDA™) is approved by the Food and Drug Administration (FDA) for the treatment of Chronic Lymphocytic Leukemia and Melphalan is a type of chemotherapy drug.

The use of Melphalan alone as a conditioning regimen for Autologous Stem Cell Transplant is considered "Standard of Care," that is, the treatment or process that your doctor would normally follow to treat your disease. Although Bendamustine (TREANDA™) has been used in multiple myeloma research studies, the combination of Bendamustine (TREANDA™) and Melphalan as treatment for Multiple Myeloma is not approved by the FDA, thus the combination therapy used in this research study is considered "investigational."

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. Patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells.
  • Patients must be age 18 or older.
  • Patients must have a life expectancy of at least 12 weeks.
  • Patients must have an ECOG performance status of 0, 1 or 2.
  • Patients must provide written informed consent.

Exclusion Criteria:

  • Impaired renal function with a measured or calculated creatinine clearance of less than 25 ml/min.
  • Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of normal (ULN) or ALT or AST greater than 5 x ULN.
  • Serious active or uncontrolled infection or medical condition.
  • Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
  • Impaired pulmonary function with a DLCO less than 45% predicted.
  • Impaired cardiac function with an ejection fraction less than 40% of predicted.
  • Other systemic anticancer therapy or ongoing toxicities from such therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916058

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: June Greenberg, R.N.    212-746-2651    jdg2002@med.cornell.edu   
Principal Investigator: Tsiporah Shore, M.D.         
Sub-Investigator: Eric Feldman, M.D.         
Sub-Investigator: Ruben Niesvizky, M.D.         
Sub-Investigator: Tomer Mark, M.D.         
Sub-Investigator: Usama Gergis, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Tsiporah Shore, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Tsiporah Shore, M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00916058     History of Changes
Other Study ID Numbers: 0812010147
Study First Received: June 5, 2009
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Multiple Myeloma
Autologous Stem Cell Transplant
ASCT
MM

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
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014