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

NCT ID: NCT00916058

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-23
• Study Completion Date: 2018-03-01

Brief Summary

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.

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."

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Level 1

Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

30 mg/m\^2 given on day 2 of melphalan

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Dose Level 2

Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Bendamustine

Intervention Type: DRUG

60 mg/m\^2 given on the 2nd day of melphalan

Dose Level 3

Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Bendamustine

Intervention Type: DRUG

90 mg/m\^2 given on the 2nd day of melphalan

Dose Level 4

Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Bendamustine

Intervention Type: DRUG

60 mg/m\^2 given on the 1st and 2nd day of melphalan

Dose Level 5

Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Bendamustine

Intervention Type: DRUG

90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan

Dose Level 6

Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Bendamustine

Intervention Type: DRUG

125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan

Phase 2

Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Bendamustine

Intervention Type: DRUG

125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan

Interventions

Bendamustine

30 mg/m\^2 given on day 2 of melphalan

Intervention Type: DRUG

Melphalan

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

Intervention Type: DRUG

Bendamustine

60 mg/m\^2 given on the 2nd day of melphalan

Intervention Type: DRUG

Bendamustine

90 mg/m\^2 given on the 2nd day of melphalan

Intervention Type: DRUG

Bendamustine

60 mg/m\^2 given on the 1st and 2nd day of melphalan

Intervention Type: DRUG

Bendamustine

90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan

Intervention Type: DRUG

Bendamustine

125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan

Intervention Type: DRUG

Other Intervention Names

Treanda; Alkeran; Treanda; Treanda; Treanda; Treanda; Treanda

Eligibility 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 Eastern Cooperative Oncology Group (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 alanine aminotransferase (ALT) or aspartate aminotransferase (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 diffusing capacity of the lung for carbon monoxide (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsiporah Shore, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

References

Gomez-Arteaga A, Mark TM, Guarneri D, Christos PJ, Gergis U, Greenberg JD, Hsu J, Mayer SA, Niesvizky R, Pearse RN, Phillips AA, Rossi A, Coleman M, van Besien K, Shore TB. High-dose bendamustine and melphalan conditioning for autologous stem cell transplantation for patients with multiple myeloma. Bone Marrow Transplant. 2019 Dec;54(12):2027-2038. doi: 10.1038/s41409-019-0587-0. Epub 2019 Jun 12.

Reference Type: DERIVED

PMID: 31190006 (View on PubMed)

Other Identifiers

0812010147

Identifier Type: -

Identifier Source: org_study_id