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CAR T-cell Therapy

RBM Regimen for Multiple Myeloma and Lymphoma

Phase 1
Waitlist Available
Led By Parastoo Dahi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, KPS ≥ 70, Males must agree to use an acceptable form of contraception, 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
Dose expansion eligibility: Histologically confirmed diagnosis of multiple myeloma, rel/ref DLBCL, or diffuse large B cell lymphoma transformed from an indolent lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new combination chemo-immuno therapy called RBM. It is made of up of different drugs and involves reinfusing the participants own stem cells. Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective, but will likely have fewer side effects.

Who is the study for?
This trial is for elderly patients aged 65-69 with certain health scores or anyone 70 and older, who have multiple myeloma or B-cell lymphoma. They must be in good physical condition, respond to previous treatments, and agree to contraception. Excluded are those with recent heart attacks or strokes, specific treatment failures, CNS involvement history, or prior stem cell transplants.Check my eligibility
What is being tested?
The RBM regimen being tested combines rituximab (an antibody), bendamustine (chemotherapy), and melphalan (another chemotherapy) followed by the patient's own stem cells reinfused back into their body. This study aims to see if RBM has fewer side effects compared to the standard BEAM regimen while treating lymphoma effectively.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation by rituximab, bone marrow suppression from chemotherapies like bendamustine and melphalan leading to anemia or infection risk increase, as well as complications from the stem cell transplant process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with multiple myeloma, relapsed/refractory DLBCL, or transformed indolent lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLT)

Trial Design

1Treatment groups
Experimental Treatment
Group I: rituximab, bendamustine & melphalan and ASCTExperimental Treatment4 Interventions
This is a phase I study of rituximab, bendamustine and melphalan (RBM) conditioning followed by ASCT in elderly patients with B-cell NHL. Conditioning regimen consist of rituximab 375 mg/m2 on days -11 and -4, bendamustine 160 mg/m2 intravenously on days -3 and -2; melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0. The conditioning timeline can be modified if there are patient scheduling conflicts. Patients who are deemed inevaluable will be replaced for the primary objective. Patients will be considered inevaluable if they don't receive one dose of conditioning regimen and are removed from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melphalan
1994
Completed Phase 3
~3530
rituximab
2000
Completed Phase 3
~2760
bendamustine
2012
Completed Phase 4
~1440

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,780 Total Patients Enrolled
154 Trials studying Lymphoma
8,680 Patients Enrolled for Lymphoma
Parastoo Dahi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Lymphoma
20 Patients Enrolled for Lymphoma

Media Library

Autologous Stem Cell Transplantation (ASCT) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03352765 — Phase 1
Lymphoma Research Study Groups: rituximab, bendamustine & melphalan and ASCT
Lymphoma Clinical Trial 2023: Autologous Stem Cell Transplantation (ASCT) Highlights & Side Effects. Trial Name: NCT03352765 — Phase 1
Autologous Stem Cell Transplantation (ASCT) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03352765 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific investigation presently have any open recruitment opportunities?

"This particular trial has already closed its recruitment period, which began on November 20th 2017 and ended August 10th 2022. If you're seeking alternative research opportunities, there are currently 2408 clinical trials recruiting for lymphoma patients and 546 studies aiming to enrol those undergoing Autologous Stem Cell Transplantation (ASCT)."

Answered by AI

How many individuals have been registered to take part in this medical experiment?

"This clinical trial has ceased to accept new participants. Initially posted on the 20th of November 2017 and last updated on August 10th 2022, it is no longer enrolling patients for this study. However, 2408 studies related to lymphoma as well as 546 trials involving Autologous Stem Cell Transplantation (ASCT) are still recruiting individuals at present."

Answered by AI

To what purpose does Autologous Stem Cell Transplantation (ASCT) generally apply?

"Autologous Stem Cell Transplantation (ASCT) is an intervention commonly prescribed to treat b-cell lymphomas, polyangium, multiple myeloma and even rheumatoid arthritis."

Answered by AI
~2 spots leftby Nov 2024