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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT03352765•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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 cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+5 more criteria

Exclusion Criteria

•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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

November 20, 2017

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

Lymphoma

Interventions

rituximab

DRUG

bendamustine

DRUG

melphalan

DRUG

Autologous Stem Cell Transplantation (ASCT)

PROCEDURE

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)