Sotatercept Combination Therapy for Multiple Myeloma

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

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

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

Trial Summary

What is the purpose of this trial?

It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or prevent the growth of cancer cells along with improving anemia and bone lesions that sometimes occur in people with multiple myeloma. This current study is the first study combining ACE 011 with lenalidomide. In this research study, the investigators are looking for the highest dose of ACE 011 that can be given with lenalidomide and dexamethasone. The investigators will also begin to collect information about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple myeloma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 2 weeks before starting the study, and you must not have taken another investigational drug within 28 days prior to the trial.

How is the drug ACE-011 (Sotatercept) unique in treating multiple myeloma?

Sotatercept (ACE-011) is unique in treating multiple myeloma because it not only targets the cancer cells but also improves bone health by increasing bone mineral density, which is often compromised in multiple myeloma patients. This dual action sets it apart from other treatments that primarily focus on attacking the cancer cells. ^{1 2 3 4 5}

Research Team

Andrew Yee, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with multiple myeloma who've had at least one prior treatment. They must not be pregnant or breastfeeding, have a decent level of physical function (ECOG 0-2), and show specific signs of the disease in their blood, urine, or bone marrow. Those needing recent radiotherapy should wait two weeks post-treatment to join.

Inclusion Criteria

Monoclonal protein present in the serum and/or urine

Not pregnant or breastfeeding

My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.

Exclusion Criteria

I do not have brain metastases.

I have allergies to medications similar to ACE 011, Lenalidomide, or Dexamethasone.

I have not had major surgery in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation Treatment

Participants receive ACE-011, lenalidomide, and dexamethasone in 28-day cycles to determine the maximum tolerated dose

2 years

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ACE-011

Trial Overview Researchers are testing Sotatercept (ACE-011) combined with Lenalidomide and Dexamethasone to find the highest safe dose against multiple myeloma. This study aims to see if this combo can slow cancer growth while helping anemia and bone issues related to the disease.

Participant Groups

Group I: ACE-011 (sotatercept) Experimental Treatment 4 Interventions

ACE-011, Lenalidomide or pomalidomide, Dexamethasone

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Multiple Myeloma Research Consortium

Collaborator

Trials

21

Recruited

1,200+

Findings from Research

Recent advancements in anti-myeloma treatments, including thalidomide, lenalidomide, and bortezomib, have shown significant clinical responses, especially in patients who do not respond to traditional chemotherapy.

The review highlights the ongoing development of various novel therapeutic classes, such as second-generation proteasome inhibitors and HDAC inhibitors, which are currently in clinical trials or advanced preclinical stages, indicating a promising expansion of treatment options for myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the bench to the bedside: emerging new treatments in multiple myeloma. Mitsiades, CS., Hayden, PJ., Anderson, KC., et al.[2023]

The introduction of 18 new treatments for multiple myeloma over the past 12 years has significantly improved patient survival rates, extending median survival by 3 to 4 times.

Current treatment strategies emphasize the use of triplet therapies for both transplant and non-transplant patients, with maintenance therapies like lenalidomide showing benefits in prolonging progression-free and overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress and Paradigms in Multiple Myeloma. Anderson, KC.[2018]

References

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

Emerging therapies for relapsed/refractory multiple myeloma: CAR-T and beyond. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Sotatercept in patients with osteolytic lesions of multiple myeloma. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

From the bench to the bedside: emerging new treatments in multiple myeloma. [2023]

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

New strategies in the treatment of multiple myeloma. [2021]

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

Progress and Paradigms in Multiple Myeloma. [2018]