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

June 5, 2009
November 4, 2010
March 2009
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00916058 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
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

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.

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."

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Multiple Myeloma
  • 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
  • Drug: Bendamustine
    60 mg/m2 given on the 2nd day of melphalan
    Other Name: Treanda
  • Drug: Bendamustine
    90 mg/m2 given on the 2nd day of melphalan
    Other Name: Treanda
  • Drug: Bendamustine
    60 mg/m2 given on the 1st and 2nd day of melphalan
    Other Name: Treanda
  • 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
  • Experimental: 1
    Dose Level 1
    Interventions:
    • Drug: Bendamustine
    • Drug: Melphalan
  • Experimental: 2
    Dose Level 2
    Interventions:
    • Drug: Melphalan
    • Drug: Bendamustine
  • Experimental: 3
    Dose Level 3
    Interventions:
    • Drug: Melphalan
    • Drug: Bendamustine
  • Experimental: 4
    Dose Level 4
    Interventions:
    • Drug: Melphalan
    • Drug: Bendamustine
  • Experimental: 5
    Dose Level 5
    Interventions:
    • Drug: Melphalan
    • Drug: Bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
March 2012
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States
 
NCT00916058
0812010147
Yes
Tsiporah Shore, M.D., Weill Cornell Medical College
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Tsiporah Shore, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP