CLINICAL TRIAL

Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

Newly Diagnosed
Relapsed
Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether melphalan hydrochloride may help prevent multiple myeloma from coming back in individuals who have undergone a stem cell transplant.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Plasma Cell Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 2 different treatments. Autologous Hematopoietic Stem Cell Transplantation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Filgrastim-sndz
BIOLOGICAL
+
Melphalan Hydrochloride
DRUG
+
Autologous Hematopoietic Stem Cell Transplantation
PROCEDURE
Experimental Group 2
Filgrastim-sndz
BIOLOGICAL
+
Melphalan Hydrochloride
DRUG
+
Autologous Hematopoietic Stem Cell Transplantation
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Melphalan
FDA approved
Autologous Hematopoietic Stem Cell Transplantation
2007
Completed Phase 3
~1570

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Multiple Myeloma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A person with a Karnofsky performance score of 70% or higher is considered to be in relatively good health. show original
Someone who registers with a left ventricular ejection fraction at rest of more than 40% within three months will be considered eligible for the study. show original
In patients with Gilbert syndrome, a bilirubin level of more than two times the upper limit of normal will be allowed. show original
Creatinine clearance of >= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation. show original
Their pulmonary function must be greater than 50% of the predicted value for their age, height, and sex within 3 months of registration. show original
All subjects who may become pregnant must agree to use effective birth control while participating in this study. show original
Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay OR Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis [serum protein electrophoresis (SPEP)] and immunofixation (serum immunofixation electrophoresis [SIFE]) and the absence of Bence Jones protein in the urine [urine protein electrophoresis (UPEP)] defined by use of conventional electrophoresis and immunofixation [urine immunofixation electrophoresis (UIFE) techniques]) but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan.
Patients who have undergone two courses of cytotoxic therapy and are within two to twelve months of the first dose of mobilizing therapy are not considered to have initial systemic therapy. show original
Signed informed consent form.
Alanine aminotransferase is slightly elevated and aspartate aminotransferase is normal. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Autologous Hematopoietic Stem Cell Transplantation will improve 2 primary outcomes and 4 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Within 30 days after the start of infusion.

Incidence of toxicity of melphalan hydrochloride
WITHIN 30 DAYS AFTER THE START OF INFUSION
Toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.
WITHIN 30 DAYS AFTER THE START OF INFUSION
Complete response rate (CR)
AT 90 DAYS POST-TRANSPLANT
CR will be estimated along with 95% posterior credible intervals, assuming beta (.50, .50) priors. The probabilities of CR from the two infusion schedules will also be compared using posterior probabilities of the form Pr(p1 < p2 | data), where pj denotes the probability of the event with schedule j=1,2, based on the data for patients treated at the optimal within-schedule dose chosen by the BMA-CRM.
AT 90 DAYS POST-TRANSPLANT
Rate of minimal residual disease (MRD)
AT DAY 90 POST-TRANSPLANT
MRD negative is defined as absence of phenotypically aberrant clonal plasma cells by nerve growth factor (NGF) on bone marrow aspirates using the EuroFlow standard operation procedure for MRD detection in multiple myeloma (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells or higher. MRD will be estimated along with 95% posterior credible intervals, assuming beta (.50, .50) priors. The probabilities of MRD from the two infusion schedules will also be compared using posterior probabilities of the form Pr(p1 < p2 | data), where pj denotes the probability of the event with schedule j=1,2, based on the data for patients treated at the optimal within-schedule dose chosen by the BMA-CRM.
AT DAY 90 POST-TRANSPLANT
Incidence of treatment related mortality (TRM)
AT DAY 90 POST-TRANSPLANT
TRM will be estimated along with 95% posterior credible intervals, assuming beta (.50, .50) priors. The probabilities of TRM from the two infusion schedules will also be compared using posterior probabilities of the form Pr(p1 < p2 | data), where pj denotes the probability of the event with schedule j=1,2, based on the data for patients treated at the optimal within-schedule dose chosen by the Bayesian Model Averaging continual reassessment method (BMA-CRM).
AT DAY 90 POST-TRANSPLANT
Progression-free survival (PFS)
FROM THE DATE OF EVOMELA INJECTION UP TO 1 YEAR
PFS will be computed from the date of Evomela injection to the last time of follow-up or the event of interest (progression or death). Unadjusted PFS distributions will be estimated by the Kaplan and Meier method.
FROM THE DATE OF EVOMELA INJECTION UP TO 1 YEAR
The Pharmacokinetics of melphalan hydrochloride parameters will assessed.
UP TO 1 YEAR
The investigators will determine pharmacokinetic parameters such as AUC (area under the curve) for each patient using the melphalan plasma concentrations at various time points described above.The investigators will also examine the correlation of theses PK parameters such as (AUC, Clearance, Cmax) with efficacy outcomes (such as OS, PFS) and toxicities (such as mucositis).
UP TO 1 YEAR

Patient Q & A Section

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

What causes multiple myeloma?

The most frequently described cause of multiple myeloma is an uncontrolled production of a monoclonal protein. In the past, it has also often been associated with exposure to ionizing radiation; the mechanisms of causation for ionizing radiation-induced multiple myeloma have not been well understood at present and are currently under intense investigation.

Anonymous Patient Answer

Can multiple myeloma be cured?

This report presents the first use of allogeneic blood stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)s to successfully treat a patient with advanced multiple myeloma. Our case illustrates the need for a more intense research effort, including improvements in the management of this rare condition and a better understanding of its biology and pathophysiology.

Anonymous Patient Answer

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

Approximately 9,600 people are diagnosed with MM a year in the United States. This is one of the highest rates among the developed (or industrialized) nations, although multiple studies have shown that MM is more common in other parts of the world. The high prevalence and incidence of MM in the United States may indicate its occurrence is related to a higher number of environmental exposures.

Anonymous Patient Answer

What are the signs of multiple myeloma?

Signs and symptoms that may lead to the discovery of multiple myeloma include: increased unexplained blood loss, unusual and persistent blood in the urine with no demonstrable organic cause, bone tenderness or pain, and pathologic fractures.\n

Anonymous Patient Answer

What is multiple myeloma?

The diagnosis of MM is based on the presence of myeloma protein in the blood and magnetic resonance imaging or computed tomography. Patients with the disorder often have low levels of Vitamin B12 or may not respond to B-synthetase inhibitors. Physicians can treat patients with MM by administering autologous stem cell transplantation.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

The development of treatment regimens with a new generation of medications and biologic agents has dramatically improved the OS of multiple myeloma patients, but unfortunately the median OS of multiple myeloma is much poorer than the median survival of patients with multiple myeloma who did not receive treatment.

Anonymous Patient Answer

What does autologous hematopoietic stem cell transplantation usually treat?

Patients with multiple myeloma-related myelodysplasia might benefit from autologous hematopoietic stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation: they may have better posttransplant and prognostic outcomes, including higher relapse-free survival and overall survival rate. Autologous hematopoietic stem cell transplantation should be considered in refractory patients with multiple myeloma-related myelodysplasia.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

Most myeloma cases appear to occur after a person has a weak or absent immune system. Because people with many types of cancer have weak or absent immune systems and also often have a weak or absent immune system, it is not quite clear how multiple myeloma develops or who is at greatest risk of developing it. It is possible that multiple myeloma is influenced by mutations in our genomes to be more likely to occur in people whose immune systems are at a greater risk of developing multiple myeloma.

Anonymous Patient Answer

Have there been other clinical trials involving autologous hematopoietic stem cell transplantation?

Many of these trials involved myelodysplastic syndromes but only few studies investigated the effects of autologous stem cell transplantation on the treatment of myeloma. This case report shows the potential benefits of this new technique which seems promising for future research and treatment of MM.

Anonymous Patient Answer

Who should consider clinical trials for multiple myeloma?

The majority of [research-eligible] MM patients support [a clinical trial] by an appropriate decision (about treatment and prognosis) when they receive the results. [For patients who may benefit, however, a clinical trial may not be an appropriate choice at this time.

Anonymous Patient Answer

How serious can multiple myeloma be?

Due to the very high and increasing incidence of multiple myeloma, and to other life-threatening illnesses, the public is increasingly aware of the risks of treatment. In this article, information on the seriousness of the disease can be found and assessed.

Anonymous Patient Answer

Has autologous hematopoietic stem cell transplantation proven to be more effective than a placebo?

Although the treatment effects and survival were comparable to those of placebo, autologous HSC transplantation was better than a placebo-only group. In a recent study, findings support the feasibility of autobahological HSC transplantation to treat MM, and the importance of developing new therapeutic modalities.

Anonymous Patient Answer
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