← Back to Search

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My lymphoma has worsened since my last treatment, or I've had a stem cell transplant, or my previous treatment included bendamustine, or I've had a heart attack or stroke in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicities (DLT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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