Status:
ACTIVE_NOT_RECRUITING
A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lymphoma
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem...
Eligibility Criteria
Inclusion
- Phase I eligibility:
- Any patient with multiple myeloma B-cell non-Hodgkin lymphoma would be eligible for phase I portion of the study.
- Dose expansion eligibility:
- Histologically confirmed diagnosis of multiple myeloma or rel/ref DLBCL, or diffuse large B cell lymphoma transformed from an indolent lymphoma Since the endpoint of the Phase I portion is safety, any patient with myeloma or B-cell NHL can be enrolled. For dose expansion study patients with myeloma and B-NHL will be analyzed separately. The PFS endpoint varies greatly amongst different types of lymphoma. In order to accurately interpret the survival data as secondary endpoint, a homogeneous cohort of patients with DLBCL will be evaluated. DLBCL is the most aggressive B-NHL with limited options. Other B-NHL's are generally more indolent and have more options available to them.
- Additional eligibility for both the phase I and dose expansion cohort:
- Patients between the ages of 65 to 69 years old with a Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) score of 3 or higher.
- Any patient age 70 years old or older, irrespective of their Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) score.
- KPS ≥ 70
- Males must agree to use an acceptable form of contraception per institutional practices.
- Complete or partial response to salvage chemotherapy by IWG Working Group Criteria
- Cardiac ejection fraction of ≥ 45%
- Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
- Creatinine clearance of ≥50 mL/min
- Completion of most recent salvage therapy within 8 weeks of enrollment
- Direct bilirubin ≤2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST ≤ 2.5 ULN.
Exclusion
- In Lymphoma: Disease progression by IWG Working Group Criteria since last therapy
- Patients with history of CNS involvement
- Prior autologous (only in lymphoma) or allogeneic stem cell transplantation
- Patients who have failed bendamustine-based regimen previously
- Patients within 6 months of MI and stroke will be excluded
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03352765
Start Date
November 20 2017
End Date
November 1 2026
Last Update
December 4 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065