Daratumumab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Arkansas for Medical Sciences, Little Rock, AR
Multiple Myeloma+1 More
Daratumumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new multiple myeloma therapy can be added to the Total Therapy approach to help patients live longer with fewer side effects.

See full description

Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Daratumumab will improve 1 primary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 48 months.

48 months
Measure the progression-free survival in patients with high risk multiple myeloma

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Study Treatment
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Daratumumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Study TreatmentInduction Chemotherapy: Carfilzomib, Thalidomide, Dexamethasone, Daratumumab , CisPlatin, Adriamycin, Cyclophosphamide and Etoposide (KTD-Dara-PACE). Autologous Stem Cell Transplant (ASCT) 1: Melphalan, Dexamethasone, ASCT. Immunological Consolidation 1: Daratumumab. Consolidation 1: Daratumumab, Carfilzomib, Dexamethasone (Dara-KD). ASCT 2 (optional): Melphalan, Dexamethasone, ASCT. Immunological Consolidation 2: Daratumumab. Maintenance: Dara-KD alternating with Daratumumab, lenalidomide, and Dexamethasone (Dara-RD) in 3-month blocks. Bortezomib may be substituted for carfilzomib throughout the regimen at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Dexamethasone
FDA approved
Daratumumab
FDA approved
Cisplatin
FDA approved
ASCT
2016
Completed Phase 2
~220
Thalidomide
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Melphalan
FDA approved
Lenalidomide
FDA approved
Carfilzomib
FDA approved
Bortezomib D-mannitol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48 months for reporting.

Closest Location

University of Arkansas for Medical Sciences - Little Rock, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Multiple Myeloma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Myeloma Prognostic Risk Signature (MyPRS) risk score ≥ 50.4
Lactate Dehydrogenase (LDH) ≥ 360 U/L (Rule out hemolysis and infection; contact PI if any doubt.)
Diagnosis of primary plasma cell leukemia.
Eastern Cooperative Oncology Group (ECOG) ≤ 2, unless solely due to symptoms of MM-related bone disease.
Patients must have a platelet count ≥ 50,000/μL, unless lower levels are explained by extensive bone marrow plasmacytosis.
Patients must have newly diagnosed active Multiple Myeloma (MM) requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
Patients must be either untreated or have not received more than four cycles of systemic MM therapy (e.g. Revlimid Dexamethasone (RD), Bortezomib Revlimid Dexamethasone (VRD). Prior bisphosphonates and localized radiation are allowed.
Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
Participants must have a baseline serum creatinine level < 3 mg/dL and baseline Alanine Aminotransferase (ALT) < 3x Upper Limit of Normal (ULN).
Participants must have an ejection fraction by echocardiogram (ECHO) or Multiple-gated Acquisition Scan (MUGA) scan ≥ 45%

Patient Q&A Section

What causes multiple myeloma?

"The cause of MM is largely still unknown and remains a subject of controversy. This may be partly because there continues to be a lack of funds for cancer research throughout the world. However, a large proportion of studies do uncover biomarkers (cancer proteins) that can be used to help identify a risk of developing the disease. On a basic level, the risk of developing MM appears to be higher among those exposed to environmental contaminants, such as those emitted by traffic, or those who live in polluted cities. Exposure to sunlight or vitamin D deficiency enhances the risk of developing MM. At a higher level, it is shown that there may be certain genes that predispose individuals to development of the disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"In early MM, fever, abdominal pain, fatigue, and low-grade Bence Jones proteinuria are usually the first clinical symptoms. In contrast, in late MM, Bence Jones proteinuria is more commonly associated with anemia, but abdominal pain and painless jaundice are more common." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"One hundred and one myeloma patients received a therapy that had proven effectiveness in at least one study (a minimum of two studies were needed for a therapy to be considered common). The majority of common therapies to myeloma are associated with significant toxicity; most of these treatments are only rarely used by patients." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"In children, high-risk acute leukemia tends not to be curable. Allogeneic stem cell transplantations are not curative, but can improve survival in children with high-risk acute leukemia. However, curative treatment is possible in children with multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma is a cancer of plasma cells. It is a type of lymphoproliferative disease. This disease can also invade structures in the brain and spinal cord, which cause symptoms. It has a poor survival rate." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"In the United States, more than 4,000 patients develop MM in 2008; most of these were in men aged 50–69 years with a newly diagnosed MM. Patients with MM in the United States have different characteristics and staging compared with patients in Europe, Australia and New Zealand (USA)." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in daratumumab for therapeutic use?

"Daratumumab demonstrated an improvement in progression-free survival compared to lenalidomide after three or more months of lenalidomide, suggesting improvements in disease dynamics of multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What is the latest research for multiple myeloma?

"The last 30 years have resulted in the most complete understanding of the [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) genome sequence. However, more work still needs to be done to fully understand the mechanisms of cancer, how the cancer begins, and how it progresses. Genetic predisposition to myeloma is not recognized as a risk factor for multiple myeloma. Further research in this area may help to understand what triggers cancer and the mechanisms involved in multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving daratumumab?

"The only registered clinical trial involving daratumumab was a phase IIa trial in combination with prednisone and bisphosphonates, in a large population of relapsed multiple myeloma patients, that did not specify response by imaging. However, several authors have indicated that the results of this trial are being interpreted in a very favorable way. As this study was registered before completion, a number of authors do not believe it has been performed. Further investigation is warranted, and the results could have major implications. In the absence of any other clinical trial to prove that daratumumab is an effective treatment, we will not recommend the injection of daratumumab for the treatment of relapsed multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of multiple myeloma?

"In a study of patients with MM, only the patient's sex and the presence of an associated plasma cell dyscrasia had a strong and significant association with a specific cause of MM. Data from a recent study are expected to be applicable to other neoplastic diseases. Patients with a specific genetic abnormality may benefit from specific treatments. A multidisciplinary approach may help in making a more definitive diagnosis and selecting a treatment for the patient." - Anonymous Online Contributor

Unverified Answer

Has daratumumab proven to be more effective than a placebo?

"The increased effectiveness of daratumumab and increased tolerability showed an important superiority over a placebo. The overall study confirms that daratumumab is a valid first line treatment option for newly diagnosed bortezomib-refractory relapsed/refractory/refractory multiple myeloma patients." - Anonymous Online Contributor

Unverified Answer

How quickly does multiple myeloma spread?

"A significant percentage of patients with MM develop MSC. The use of BMPC in MM patients, either as a sole or main therapy, may result in long-term improvement of disease in patients with MM and MSC." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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