Dose Modifications for Multiple Myeloma and Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if specific dosing guidelines can help individuals with a Duffy null phenotype, who are treated for multiple myeloma or triple negative breast cancer, avoid dose changes and fevers due to low white blood cells. Researchers will evaluate how these guidelines interact with common cancer drugs like daratumumab (a monoclonal antibody therapy) and paclitaxel (a chemotherapy drug). Suitable candidates for this trial include those diagnosed with either multiple myeloma or stage II/III triple negative breast cancer and confirmed to have the Duffy null phenotype. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have examined the safety of the treatments used in this trial for people with multiple myeloma and triple-negative breast cancer.
For multiple myeloma, research has shown that the drugs daratumumab, lenalidomide, bortezomib, and dexamethasone are generally well-tolerated, though side effects can occur. Daratumumab has been used for several years, and long-term studies have not identified new safety concerns. However, many patients still experience severe side effects during treatment. Lenalidomide can increase the risk of blood clots and heart problems, especially when combined with dexamethasone. Bortezomib is known for its effectiveness and manageable side effects, though some patients report serious side effects.
For triple-negative breast cancer, the safety of pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide has been studied. Pembrolizumab has shown an acceptable safety profile in early breast cancer, although some side effects are related to the immune system. Paclitaxel and carboplatin are generally well-tolerated, but serious side effects have been reported in some cases. Doxorubicin and cyclophosphamide have been shown to be safe and effective when used together, though they can also cause significant side effects.
Overall, while these treatments are effective, they come with potential risks. Participants should discuss any concerns with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores dose modifications based on the Duffy Null phenotype for treating Multiple Myeloma and Triple-Negative Breast Cancer. Unlike standard treatments, this approach tailors dosage adjustments to genetic profiles, potentially enhancing efficacy and reducing side effects. For Multiple Myeloma, the treatment combines drugs like daratumumab and lenalidomide, aiming to improve outcomes by personalizing care. In Triple-Negative Breast Cancer, the trial uses a regimen including pembrolizumab and carboplatin, with adjustments based on genetic markers to optimize the impact. By focusing on genetic differences, this trial could lead to more effective, individualized cancer therapies.
What evidence suggests that this trial's treatments could be effective for multiple myeloma and triple negative breast cancer?
In this trial, participants with multiple myeloma will receive a combination of daratumumab, bortezomib, lenalidomide, and dexamethasone. Research has shown that this combination effectively treats multiple myeloma. Specifically, studies indicate that adding daratumumab significantly improves survival rates compared to using only bortezomib and dexamethasone, reducing the risk of death by 26%.
For participants with triple-negative breast cancer, the treatment involves combining pembrolizumab with chemotherapy. Studies have demonstrated that this combination greatly increases the chances of achieving a pathologic complete response, meaning no cancer is found in tissue samples after treatment. It also improves overall survival rates, establishing it as the new standard of care.678910Who Is on the Research Team?
Andrew Hantel, MD
Principal Investigator
MD
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Duffy null phenotype who need treatment for multiple myeloma or stage II/III triple negative breast cancer. It includes those on specific chemotherapy regimens, even if treatments extend beyond initial cycles or vary from the planned drugs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Multiple Myeloma
Participants with Multiple Myeloma receive Bortezomib, Daratumumab, Lenalidomide, and Dexamethasone over a 28-day cycle for 6 cycles
Treatment - Triple Negative Breast Cancer
Participants with Triple Negative Breast Cancer receive Paclitaxel, Carboplatin, and Pembrolizumab for 4 cycles, followed by Doxorubicin, Cyclophosphamide, and Pembrolizumab for another 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Observational and Survey Studies
Participants may opt into observational studies and complete surveys to compare health experiences between Duffy null and non-Duffy null populations
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Carboplatin
- Cyclophosphamide
- Daratumumab
- Dexamethasone
- Doxorubicin
- Lenalidomide
- Paclitaxel
- Pembrolizumab
Trial Overview
The study tests whether tailored dosing guidelines for individuals with Duffy null phenotype can reduce dose changes and prevent fever due to low neutrophils during treatment. It compares these outcomes to patients without this phenotype receiving standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with Triple Negative Breast Cancer and identified Duffy Null phenotype will receive standard of care (Keynote-522) per institutional protocol with dosage adjustments per Duffy-Null guidance Study treatment cycle lasts 21 days * Pembrolizumab 1x every 21 days on day 1 for cycles 1-4 * Paclitaxel 1x weekly on D1, 8, and 15 for cycles 1-4 * Carboplatin 1x weekly on D1, 8, and 15 for cycles 1-4 * Doxorubicin 1x every 14 days for cycles 5-8 * Cyclophosphamide 1x every 14 days for cycles 5-8 * Pembrolizumab 1x every 21 days on day 1 for cycles 5-8
Participants with Multiple Myeloma and identified Duffy Null phenotype will receive standard of care (Dara-RVD) per institutional protocol with dosage adjustments per Duffy-Null guidance. Study treatment cycle lasts 28 days * dexamethasone 1X daily on days 1, 2, 8, 9, 15, 16, 22, 23 for 6 cycles * lenalidomide 1x daily on days 1-21 for 6 cycles * bortezomib 1x weekly for 2 cycles * daratumumab 1x weekly up to 2 cycles, then every 14 days for 4 more cycles
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andrew Hantel, MD
Lead Sponsor
Citations
Daratumumab, Bortezomib, Lenalidomide, and ...
An evaluation of subcutaneous daratumumab combined with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of transplantation-eligible patients
Overall Survival With Daratumumab, Bortezomib, and ...
At a median follow-up of 72.6 months, D-Vd significantly prolonged OS, with a 26% reduction in the risk of death versus bortezomib and dexamethasone alone ( ...
3.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/647/503047/Comparison-of-Response-and-Survival-Outcomes-inComparison of Response and Survival Outcomes in Standard ...
Conclusions: D-RVD is a highly effective induction regimen that can improve upon outcomes in a historical NDMM population treated with RVD in ...
the randomized phase 3 CEPHEUS trial
Frontline daratumumab-based triplet and quadruplet standard-of-care regimens have demonstrated improved survival outcomes in newly diagnosed ...
Pembrolizumab for Early Triple-Negative Breast Cancer
Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative ...
Velcade Label - accessdata.fda.gov
Integrated Summary of Safety (Relapsed Multiple Myeloma and Mantle Cell Lymphoma). Safety data from phase 2 and 3 studies of single agent VELCADE 1.3 mg/m. 2.
The safety of bortezomib for the treatment of multiple ...
Bortezomib is an important part of current anti-myeloma therapy with a good clinical efficacy and manageable side effects.
Velcade (Bortezomib) & Multiple Myeloma Treatment | IMF
Velcade (bortezomib) is approved by the FDA for use throughout the myeloma disease course, in combination with nearly all other FDA-approved anti-myeloma ...
9.
mayoclinic.org
mayoclinic.org/drugs-supplements/bortezomib-intravenous-route-subcutaneous-route/description/drg-20067371Bortezomib (intravenous route, subcutaneous route)
Bortezomib injection is used to treat multiple myeloma (blood plasma ... Safety and efficacy have not been established in children with ...
10.
ema.europa.eu
ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdfVelcade, INN-bortezomib - European Medicines Agency (EMA)
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with VELCADE at 1.3 mg/m2 and included in Table 7.
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