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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Bendamustine; Drug: Melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT00916058

0812010147

Details and patient eligibility

About

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.

Full 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."

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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57 participants in 7 patient groups

Dose Level 1

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Dose Level 2

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Dose Level 3

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Dose Level 4

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Dose Level 5

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Dose Level 6

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Phase 2

Experimental group

Description:

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)

Treatment:

Drug: Bendamustine

Drug: Melphalan

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine

Drug: Bendamustine