Bendamustine + Pomalidomide + Dexamethasone for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cristina Gasparetto

Must be taking: Enteric coated aspirin

Must not be taking: Experimental drugs, Chemotherapy

Disqualifiers: Heart failure, Hypertension, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a combination of three drugs—Bendamustine, Pomalidomide, and Dexamethasone—to find an effective treatment for multiple myeloma, a type of blood cancer. The goal is to determine the best dosage and assess how well this combination works for patients whose cancer has returned or did not respond to previous treatments. Different groups receive slightly varied doses to find the optimal balance. This trial may suit those diagnosed with multiple myeloma who have not had success with lenalidomide and are experiencing a relapse or progression of the disease. As a Phase 1/Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group, offering a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used experimental drugs, chemotherapy, or steroids within 14-21 days before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of bendamustine, pomalidomide, and dexamethasone has been tested for safety in people with multiple myeloma, a type of blood cancer. Studies have found that this combination is generally well-tolerated.

Bendamustine is already used for multiple myeloma that has returned or hasn't responded to other treatments. Patients in studies have generally managed this treatment well, though, like many cancer treatments, it can have side effects. These may include low blood counts, which can increase the risk of infection, as well as tiredness and nausea.

Pomalidomide and dexamethasone are often used together to treat multiple myeloma and are also considered generally safe. However, they can cause side effects like low blood cell counts and a higher risk of blood clots.

Overall, evidence suggests this treatment combination has been safe for many patients, but side effects can differ from person to person. Regular check-ups and discussions with healthcare providers are important while on treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for multiple myeloma because they combine bendamustine, pomalidomide, and dexamethasone in a new way that could enhance effectiveness against the cancer cells. Unlike traditional treatments, which often rely on separate mechanisms, this combination potentially offers a synergistic effect, targeting the cancer in multiple ways. Pomalidomide, which modulates the immune system, is given with bendamustine, a chemotherapy drug, and dexamethasone, a steroid, potentially enhancing the overall treatment response while maintaining a convenient dosing schedule. This approach could improve outcomes for patients who have not responded well to existing therapies.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Studies have shown that the combination of Bendamustine, Pomalidomide, and Dexamethasone (BPD) holds promise for treating relapsed or refractory multiple myeloma, a type of blood cancer. This trial will evaluate different dosages of Pomalidomide within the BPD combination. Research indicates that patients treated with BPD often live longer, making it a strong option for those whose previous treatments have failed. The combination is practical and effective even for patients who have undergone many treatments, suggesting they may still benefit from it. ^{1 4 5 6 7}

Who Is on the Research Team?

Gwynn Long, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed or refractory multiple myeloma, who have seen their cancer progress after treatment, including lenalidomide. They should have a life expectancy of more than 3 months and be able to perform daily activities with minimal assistance (ECOG Performance Status of 0-2). Their liver function must also meet certain criteria.

Inclusion Criteria

Consent

My diagnosis of multiple myeloma is confirmed through testing.

I can have blood transfusions if needed for my health.

Exclusion Criteria

I haven't taken chemotherapy or steroids in the last 14 days.

I have previously taken pomalidomide.

I have not had radiation therapy in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients are enrolled in cohorts to determine the maximum tolerated dose (MTD) using a 3+3 design

2 months

Multiple visits for dose escalation and monitoring

Treatment

Participants receive Bendamustine, Pomalidomide, and Dexamethasone in 28-day cycles for up to 12 cycles

12 months

Monthly visits for treatment administration and monitoring

Maintenance

Participants continue with Pomalidomide and Dexamethasone until disease progression

Until progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Bendamustine
• Dexamethasone
• Pomalidomide

Trial Overview

The study tests a combination of three drugs: Pomalidomide taken orally for the first 21 days of each cycle, Bendamustine given intravenously on day one, and Dexamethasone administered weekly either orally or IV. After initial cycles, doses may adjust and continue until disease progression.

How Is the Trial Designed?

Group I: Expansion Experimental Treatment 3 Interventions

* Pomalidomide 3mg: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine 120 mg: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Group II: Cohort 2: benda 120mg + pom 4mg Experimental Treatment 3 Interventions

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Group III: Cohort 1: benda 120mg + pom 3mg Experimental Treatment 3 Interventions

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Treanda for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in European Union as Ribomustin for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma
• Multiple myeloma

Approved in Canada as Levact for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in Japan as Bendamustine hydrochloride for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Who Is Running the Clinical Trial?

Cristina Gasparetto

Lead Sponsor

Trials

3

Recruited

110+

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01754402

NCT01754402 | Bendamustine + Pomalidomide + Dex in R ...

This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: Pomalidomide: once daily ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10443238/

Efficacy of Bendamustine, Pomalidomide, and ...

Conclusions: The BPD regimen demonstrated promising effectiveness in RREMM patients, yielding favorable ORR and survival rates. To corroborate ...

3.

ovid.com

ovid.com/journals/bjha/pdf/10.1111/bjh.18200~bendamustine-in-combination-with-pomalidomide-and

Bendamustine in combination with pomalidomide and ...

Combination of bendamustine, lenalidomide, and dexametha- sone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: ...

4.

bloodresearch.or.kr

bloodresearch.or.kr/journal/view.html?uid=1816&vmd=Full

Bendamustine in heavily pre-treated multiple myeloma ...

Survival outcomes for patients with MM have substantially improved over the last two decades due to treatment with high-dose chemotherapy ...

5.

conference-correspondent.com

conference-correspondent.com/highlights/asco/phase-1-2-dose-expansion-of-a-trial-investigating-bendamustine-and-pomalidomide-with-dexamethasone-in-patients-with-rrmm

Phase 1/2 Dose Expansion of a Trial Investigating ...

The combination of bendamustine and pomalidomide with dexamethasone shows promise in patients with relapsed/refractory multiple myeloma (RRMM).

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37803841/

Bendamustine combined with pomalidomide and ...

Objective: To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone (BPD regimen) in the treatment ...

7.

myeloma.org

myeloma.org/treatment/multiple-myeloma-medications/treanda-or-bendeka-bendamustine

TREANDA or BENDEKA (bendamustine)

Many studies show that it is an effective treatment in relapsed/refractory multiple myeloma (RRMM), and it is recognized as a treatment option by the National ...