CLINICAL TRIAL

Allogeneic Hematopoietic Stem Cell Transplantation for Recurrent Plasma Cell Myeloma

Waitlist Available · Any Age · All Sexes · Houston, TX

Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

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About the trial for Recurrent Plasma Cell Myeloma

Eligible Conditions
Recurrent Plasma Cell Myeloma · Precursor Cell Lymphoblastic Leukemia-Lymphoma · Recurrent Myelodysplastic Syndrome · Hematopoietic and Lymphoid Cell Neoplasm · High Risk Acute Myeloid Leukemia · Leukemia, Myeloid · Myelodysplastic Syndromes (MDS) · Leukemia, Myeloid, Acute · Lymphoproliferative Disorders · Recurrent High Risk Myelodysplastic Syndrome · Myeloproliferative Disorders · Myelodysplastic-Myeloproliferative Diseases · Syndrome · Lymphoma · Neoplasms · Preleukemia · Myelodysplastic Syndromes · Disorders, Lymphoproliferative · Myelodysplastic/Myeloproliferative Neoplasms · acute, recurrent Myeloid Leukemia · Recurrent Non-Hodgkin Lymphoma · Recurrent Hodgkin Lymphoma · Leukemia · Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Multiple Myeloma · High-risk Myelodysplastic Syndrome (MDS) · Recurrent Acute Lymphoblastic Leukemia

Treatment Groups

This trial involves 6 different treatments. Allogeneic Hematopoietic Stem Cell Transplantation is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Allogeneic Hematopoietic Stem Cell Transplantation
PROCEDURE
+
Busulfan
DRUG
+
Thiotepa
DRUG
+
Mycophenolate Mofetil
DRUG
+
Tacrolimus
DRUG
+
Fludarabine
DRUG
+
Pharmacological Study
OTHER
+
Cyclophosphamide
DRUG
+
Fludarabine Phosphate
DRUG
+
Laboratory Biomarker Analysis
OTHER
Experimental Group 2
Allogeneic Hematopoietic Stem Cell Transplantation
PROCEDURE
+
Busulfan
DRUG
+
Tacrolimus
DRUG
+
Fludarabine
DRUG
+
Pharmacological Study
OTHER
+
Cyclophosphamide
DRUG
+
Fludarabine Phosphate
DRUG
+
Laboratory Biomarker Analysis
OTHER
Experimental Group 3
Allogeneic Hematopoietic Stem Cell Transplantation
PROCEDURE
+
Busulfan
DRUG
+
Thiotepa
DRUG
+
Mycophenolate Mofetil
DRUG
+
Tacrolimus
DRUG
+
Fludarabine
DRUG
+
Pharmacological Study
OTHER
+
Cyclophosphamide
DRUG
+
Fludarabine Phosphate
DRUG
+
Laboratory Biomarker Analysis
OTHER
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2015
Completed Phase 2
~1180
Busulfan
FDA approved
Tromethamine
FDA approved
Mycophenolate mofetil
FDA approved
Tacrolimus
FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Recurrent Plasma Cell Myeloma or one of the other 27 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with high-risk hematologic malignancies with anticipated poor prognosis with non transplant therapy, including those in remission or with induction failure and after treated or untreated relapse; Diagnoses to be included a) Acute myeloid leukemia; b) Acute lymphocytic leukemia; c) Chronic myeloid leukemia; d) Chronic lymphoproliferative disorder; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkin's lymphoma; h) Hodgkin's Lymphoma; i) Multiple myeloma
Patients must have a haploidentical related donor or a fully matched related or unrelated donor Performance score of >= 70 by Karnofsky/Lansky or performance score (PS) 0 to 1 (Eastern Cooperative Oncology Group [ECOG] =< 1)
Left ventricular ejection fraction >= 50%
Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin and/or volume; children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >= 92% on room air
Creatinine clearance (calculated creatinine clearance by Cockcroft-Gault using adjusted body weight if actual body weight is 20% greater than ideal is permitted) should be > 50 ml/min
Bilirubin =< 2 x the upper limit of normal (except with patients high indirect bilirubin due to Gilbert's syndrome, hypersplenism, or hemolysis)
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 200
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Patient or patient's legal representative able to sign informed consent
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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 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
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 Allogeneic Hematopoietic Stem Cell Transplantation will improve 1 primary outcome and 8 secondary outcomes in patients with Recurrent Plasma Cell Myeloma. Measurement will happen over the course of 100 days.

Non-relapse mortality rate
100 DAYS
The proportion of patients with non-relapse mortality will be reported separately by arm, along with the corresponding 95% Bayesian credible interval.
Incidence of acute and chronic graft versus host disease
UP TO 3 YEARS
Will be estimated using the method of Gooley, and the method of Fine and Gray will be used to model the incidence by disease and clinical characteristics of interest, including matched versus mismatched donors.
Incidence of grade 3 and 4 adverse events
UP TO 3 YEARS
Descriptive statistics will be used to summarize adverse events by treatment arm. The number and proportion of subjects with treatment emergent adverse events will be reported and compared between patients with matched and mismatched donors by using Fisher's exact test. Frequency counts and percentages will also be presented of subjects with serious adverse events and adverse events leading to withdrawal. Graphical summaries will be used where appropriate.
Non-relapse mortality
UP TO 3 YEARS
The proportion of patients with non-relapse mortality will be reported separately by arm, along with the corresponding 95% Bayesian credible interval.
Relapse rate
UP TO 3 YEARS
Will be observed.
Time to platelet and neutrophil engraftment
UP TO 3 YEARS
Will be calculated from the time of transplant and estimated by the Kaplan-Meier method. Distributions will be compared between patients with matched and mismatched donors via the log-rank test.
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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 are common treatments for hematopoietic and lymphoid cell neoplasm?

The treatments of lymphoma & leukemia have not changed drastically from the 1980s to the 1990s. Both, chemotherapy and radiotherapy are routinely prescribed to patients, but with small improvement over time..

question: Does new and more promising therapeutic approaches for the treatment of human osteosarcoma : combined use of new small molecules and conventional anticancer agents? answer: Because of small response rates to single therapies, new and more promising approaches for therapy of human osteosarcoma seem to be necessary. Because of the small number of osteosarcoma cells and their short-range migration, it is possible to achieve this effect by applying a new class of the anticancer agents.

Anonymous Patient Answer

What are the signs of hematopoietic and lymphoid cell neoplasm?

Hematopoietic and lymphoid cell neoplasms are associated with unexplained fevers or malaise. Lymphadenopathy or lymphedema may occur. Cutaneous lesions may demonstrate erythema nodosum, plaques, or purpuric eruptions, or may even prove to be a primary hematopoietic or lymphoid tissue neoplasm.

Anonymous Patient Answer

How many people get hematopoietic and lymphoid cell neoplasm a year in the United States?

Every year, around 2.9 million people are diagnosed with HLN in the United States. The cancer occurs mainly in infants and young children (1.0–4.3 years); however, most cases occur among adults (20–44 years of age). The cancer is more common among males (1.4 times more likely). Around 11% of people with HLN die each year. Most (61%), but not all, of them are untreated. More than 50% (49,900 patients) of children and almost a third (30,000) of adults with HLN will continue to have an illness for more than 5 years.

Anonymous Patient Answer

What causes hematopoietic and lymphoid cell neoplasm?

Most of the cancers are caused by the excess proliferation of normal tissues, especially the hematopoietic and lymphoid tissue. These organs are not the source of metastasis in most cases.

Anonymous Patient Answer

What is hematopoietic and lymphoid cell neoplasm?

Lymphomas are generally rare among Caucasians and blacks, but are much more frequent among Chinese. Chronic lymphocytic disorders occur mostly in Western countries, but are most common in the Orient. In the United States solid tumors, leukemia, lymphoma, myeloma, and histiocytosis appear most commonly in Caucasians and blacks. In this country, histiocytosis occurs more often and lymphomas are more frequent among blacks.

Anonymous Patient Answer

Can hematopoietic and lymphoid cell neoplasm be cured?

For hematopoietic and lymphoid cell neoplasm, the cure rate is not high even when standard treatments are given. The cure rate for metastatic patients was comparable with that for patients with localized lesions; however, patients with stage III and IV disease had a longer overall survival.

Anonymous Patient Answer

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

Recent findings of this meta-analysis indicate that HST is no more effective than placebo in GVHD prophylaxis and the GVHD/cITR ratio in patients with advanced hematologic malignancies.

Anonymous Patient Answer

What is allogeneic hematopoietic stem cell transplantation?

It is still uncertain to what extent MHC gene expression in HSCs contribute to MHC-associated GVHD. Furthermore, the usefulness of HSCs from unrelated HLA-mismatched donors for allogeneic HSC transplantation has not yet been proven.

Anonymous Patient Answer

What are the chances of developing hematopoietic and lymphoid cell neoplasm?

The cumulative incidence for HL and ALN was 14.7% and 23.6%, respectively. The cumulative incidence was not statistically significant compared with that in the general population, but the difference was significant in the age> or = 65 yr group (HL: 35.7% vs. 31.8%; ALN: 15.3% vs. 13.9%; p=0.02). In a subgroup study, the cumulative incidence of ALN was statistically significant in women of age<65 yr (31.8% vs. 6.6%; p=0.00), and a significant trend was identified for age>65 yr (15.3% vs. 11.7%; p=0.06).

Anonymous Patient Answer

Does allogeneic hematopoietic stem cell transplantation improve quality of life for those with hematopoietic and lymphoid cell neoplasm?

Allogeneic HSCT improves the quality of life of HR+ and HR- patients with hematopoietic and lymphoid cell neoplasms. Those patients who have a more favorable response to HSCT have better health-related quality of life. This should be considered in selecting patients to receive HSCT.

Anonymous Patient Answer

Who should consider clinical trials for hematopoietic and lymphoid cell neoplasm?

The decision to enroll a patient in a hematopoietic and lymphoid cell neoplasm CLN trial requires consideration of both individual and societal factors. The advantages and disadvantages of clinical trials need to be evaluated in a way that is patient- and clinician-specific and then [defined based on relevant medical evidence and professional guidelines] adjusted based on each person's life expectancy, disease status, and personal preferences.

Anonymous Patient Answer

What is the primary cause of hematopoietic and lymphoid cell neoplasm?

The most common cause of HLN is HHV8-associated MCD. This disorder can develop at any age but is more common in pregnant women and men between 10 and 18 years old. Although women are more likely than men to develop the disorder, men and women with the disorder are at the same risk of death. The treatment of choice for HLN is the use of antiviral agents against HHV8.

Anonymous Patient Answer
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