Vitamin D + Lenalidomide for Multiple Myeloma

Overseen By GCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Amany Keruakous, MD, MS.

Must be taking: Lenalidomide

Must not be taking: Investigational agents

Disqualifiers: Amyloidosis, Progressive disease, Hepatitis B, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 120

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT. Post ASCT arm 1 will have lenalidomide and maintenance VitD, and arm 2 will receive lenalidomide and no maintenance VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to take and swallow oral medication and comply with certain requirements related to lenalidomide. It's best to discuss your current medications with the trial team.

What evidence supports the effectiveness of the drug lenalidomide for treating multiple myeloma?

Research shows that lenalidomide, especially when combined with dexamethasone, is effective in treating multiple myeloma, leading to longer periods without disease progression and improved survival rates. It is generally well tolerated and has been approved by the FDA for use in patients with relapsed multiple myeloma. ^{1 2 3 4 5}

Is the combination of Vitamin D and Lenalidomide safe for treating multiple myeloma?

Lenalidomide, used in treating multiple myeloma, is generally safe but can cause some serious side effects like low blood cell counts and blood clots. It is less toxic than thalidomide, but careful monitoring is needed to manage these risks. ^{3 5 6 7 8}

What makes the drug combination of Vitamin D and Lenalidomide unique for treating multiple myeloma?

The combination of Vitamin D and Lenalidomide for multiple myeloma is unique because it pairs an immunomodulatory drug, Lenalidomide, known for its potent anti-tumor effects, with Vitamin D, which may enhance immune function. This combination could potentially offer a novel approach by leveraging the immune-boosting properties of Vitamin D alongside Lenalidomide's ability to directly target cancer cells and improve patient outcomes. ^{2 3 4 6 9}

Research Team

Amany Keruakous, MD

Principal Investigator

Georgia Cancer Center at Augusta University

Eligibility Criteria

This trial is for adults with multiple myeloma who can take blood clot prevention meds and comply with specific program requirements. They must be eligible for or have completed a stem cell transplant within the last 120 days, able to swallow pills, and not have other cancers or known allergies to Vitamin D supplements.

Inclusion Criteria

I have been diagnosed with multiple myeloma and do not have amyloidosis.

I can swallow pills without any issues.

I am willing to take blood clot prevention medication and follow the lenalidomide program.

Exclusion Criteria

I have been diagnosed with another type of cancer before.

I have had a previous organ or stem cell transplant.

I am allergic to the study drug (Vitamin D3).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplantation

Participants receive maintenance Vitamin D3 or no maintenance Vitamin D prior to autologous stem cell transplantation (ASCT)

Up to 120 days

Regular visits for assessment

Post-Transplantation Treatment

Participants receive lenalidomide with or without maintenance Vitamin D post-ASCT

3 years

Regular follow-up visits

Follow-up

Participants are monitored for safety, overall response rate, progression-free survival, and overall survival

3 years

Periodic assessments at 120 days, 2 years, and 3 years

Treatment Details

Interventions

• Lenalidomide
• Vitamin D - Intensified
• Vitamin D - Therapeutic

Trial Overview The study compares two groups: one taking lenalidomide with high-dose Vitamin D (intensified regimen) and another taking lenalidomide with standard-dose Vitamin D (therapeutic regimen). It aims to see how these affect immune recovery post-transplant and survival without disease progression over three years.

Participant Groups

Group I: Maintenance Vitamin D Experimental Treatment 2 Interventions

In this arm, patients will receive maintenance Vitamin D3 prior to autologous transplantation (ASCT). Within 120 days after ASCT the following will be assessed: vitamin D level, Overall Response Rate (ORR) and Measurable Residual Disease (MRD). Then patients will receive lenalidomide and continuation of maintenance Vitamin D.

Group II: No Maintenance Vitamin D Active Control 2 Interventions

In this arm, patients will receive no maintenance vitamin D prior to ASCT. Within 120 days after ASCT the following will be assessed: vitamin D level, ORR, and MRD. Then patients will receive the standard lenalidomide dose along with no maintenance vitamin D.

Lenalidomide is already approved in European Union, United States for the following indications:

Approved in European Union as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Approved in United States as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Who Is Running the Clinical Trial?

Amany Keruakous, MD, MS.

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

Lenalidomide (Revlimid) has been rapidly developed and recently approved for treating relapsed multiple myeloma, showing durable clinical responses, especially when combined with dexamethasone.

Clinical trials indicate that lenalidomide is generally well tolerated by patients, with manageable side effects, making it a promising option for those with relapsed and refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in multiple myeloma. Richardson, PG., Mitsiades, C., Hideshima, T., et al.[2018]

Lenalidomide, when combined with dexamethasone, significantly improves time to progression in patients with multiple myeloma compared to placebo, as shown in two randomized, double-blind studies.

However, the treatment is associated with serious side effects, including increased risks of neutropenia, thrombocytopenia, and thromboembolic events, leading to its restricted distribution under the RevAssist program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. Hazarika, M., Rock, E., Williams, G., et al.[2020]

Lenalidomide significantly improves progression-free survival (PFS) in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation, as shown in randomized trials like the FIRST and MM-015 trials.

Continuous lenalidomide therapy is associated with less toxicity compared to thalidomide, maintaining tolerability without increasing the risk of neutropenia or second primary malignancies, making it a safer long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a review of its continuous use in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation. McCormack, PL.[2018]

Lenalidomide has become a crucial treatment option for multiple myeloma and del-5q myelodysplastic syndromes, and it has been tested for various other cancers, showcasing its broad therapeutic potential.

The drug received FDA approval for use in combination with dexamethasone for previously treated multiple myeloma, highlighting its efficacy and safety in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. Galustian, C., Dalgleish, A.[2019]

Lenalidomide maintenance therapy significantly prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma after autologous stem-cell transplantation, as shown in pivotal phase 3 trials like IFM 2005-02 and CALGB 100104.

While lenalidomide is associated with some increased risks, such as grade 3/4 adverse events and a higher chance of second primary cancers, the overall survival benefits outweigh these risks, making it a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: A Review in Newly Diagnosed Multiple Myeloma as Maintenance Therapy After ASCT. Syed, YY.[2018]

Lenalidomide is an effective treatment for patients with relapsed or refractory multiple myeloma, showing promising clinical activity and is approved by the FDA.

Common side effects of lenalidomide include neutropenia, thrombocytopenia, and thromboembolic events, necessitating careful monitoring to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. Tariman, JD.[2018]

Lenalidomide is a more potent and less toxic alternative to thalidomide, showing significant efficacy in treating relapsed or refractory multiple myeloma, both as a single agent and in combination with other treatments.

While lenalidomide leads to high response rates and improved survival in multiple myeloma patients, it carries a risk of thromboembolism, particularly when used with steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of plasma cell dyscrasias with lenalidomide. Dimopoulos, MA., Kastritis, E., Rajkumar, SV.[2018]

Lenalidomide is a powerful treatment for multiple myeloma (MM) that works by directly causing cancer cell death, preventing cancer cells from sticking to bone marrow, and enhancing the body's immune response against tumors.

In combination with dexamethasone, lenalidomide has shown superior effectiveness in clinical trials, leading to improved patient outcomes such as longer survival and FDA approval for treating relapsed MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. Hideshima, T., Raje, N., Richardson, PG., et al.[2021]

References

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

Long-term results of response to therapy, time to progression, and survival with lenalidomide plus dexamethasone in newly diagnosed myeloma. [2018]

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

Lenalidomide in multiple myeloma. [2018]

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

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Lenalidomide: a review of its continuous use in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Lenalidomide: a novel anticancer drug with multiple modalities. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Lenalidomide: A Review in Newly Diagnosed Multiple Myeloma as Maintenance Therapy After ASCT. [2018]

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

Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of plasma cell dyscrasias with lenalidomide. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

A review of lenalidomide in combination with dexamethasone for the treatment of multiple myeloma. [2021]