RBM Regimen for Multiple Myeloma and Lymphoma

Overseen By Paul Hamlin, MD

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: CNS involvement, Prior transplant, MI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

28 Participants Needed

Trial Summary

Do I need to stop my current medications for the RBM trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the RBM regimen for treating multiple myeloma and lymphoma?

Research shows that bendamustine, a key component of the RBM regimen, has been effective in treating multiple myeloma, especially when combined with other drugs like melphalan and dexamethasone. Studies have demonstrated that bendamustine can induce responses in patients resistant to other treatments, making it a promising option for improving outcomes in multiple myeloma. ^{1 2 3 4 5}

What makes the RBM Regimen treatment for Multiple Myeloma and Lymphoma unique?

The RBM Regimen is unique because it combines bendamustine, melphalan, and rituximab with autologous stem cell transplantation (ASCT), offering a novel approach by integrating these drugs, which have different mechanisms of action, to potentially enhance treatment efficacy for multiple myeloma and lymphoma. This regimen is distinct from standard treatments as it leverages the unique properties of bendamustine, which has both alkylating and antimetabolite properties, and rituximab, a monoclonal antibody, to target cancer cells more effectively. ^{1 4 5 6 7}

What is the purpose of this trial?

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.

Research Team

Parastoo Dahi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with multiple myeloma, relapsed/refractory DLBCL, or transformed indolent lymphoma.

I have multiple myeloma or B-cell non-Hodgkin lymphoma.

Exclusion Criteria

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

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive rituximab, bendamustine, and melphalan as conditioning regimen before autologous stem cell transplantation

11 days

Multiple visits for drug administration

Autologous Stem Cell Transplantation

Reinfusion of participants' own stem cells

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Autologous Stem Cell Transplantation (ASCT)
• Bendamustine
• Melphalan
• Rituximab

Trial Overview 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.

Participant Groups

Group I: rituximab, bendamustine & melphalan and ASCT Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Bendamustine, lenalidomide and dexamethasone (BRd) has high activity as 2nd -line therapy for relapsed and refractory multiple myeloma - a phase II trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Bendamustine in multiple myeloma. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

High-Dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) Conditioning Before Autologous Transplantation for Patients With Multiple Myeloma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I/II trial of bendamustine, ixazomib, and dexamethasone in relapsed/refractory multiple myeloma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A retrospective, matched paired analysis comparing bendamustine containing BeEAM versus BEAM conditioning regimen: results from a single center experience. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Z-BeEAM (Ibritumomab tiuxetan, Bendamustine, Etoposide, Cytarabine, Melphalan) before autologous stem cell transplantation is safe and efficient for refractory large B-cell lymphoma. [2020]