New chemo cocktail aims to make stem cell transplants safer for seniors
NCT ID NCT03352765
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a combination of three drugs (rituximab, bendamustine, and melphalan) followed by a stem cell transplant using the patient's own cells. The goal is to see if this approach is safe and has fewer side effects than standard treatments for older adults with multiple myeloma or relapsed/refractory B-cell lymphoma. The study enrolls 28 patients and focuses on finding the right dose and monitoring for serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab, bendamustine, and melphalan (chemotherapy and immunotherapy drugs)
- What this could lead to
- If this works, it could offer a safer transplant option for older patients with lymphoma or myeloma, with fewer side effects than standard treatments.
- What could go wrong
- This is a very early phase I trial with only 28 participants, so it is not yet clear if the treatment is effective. The main goal is safety, and there is a risk of serious side effects from the chemotherapy and transplant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2017
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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