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Alkylating agents

Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma

Phase 2
Waitlist Available
Led By Srinivas Devarakonda, M.D.
Research Sponsored by Srinivas Devarakonda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-transplant
Awards & highlights

Study Summary

This trial is studying a reduced intensity conditioning regimen as a treatment for relapsed multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2-year Progression-free Survival (PFS)
Secondary outcome measures
1- Year GVHD-free Relapse-free Survival (GRFS)
1-year Cumulative Incidence TRM
100-day Cumulative Incidence of Treatment-related Mortality (TRM)
+7 more
Other outcome measures
Rate of Minimal Residual Disease-negativity

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (conditioning regimen, stem cell transplant)Experimental Treatment7 Interventions
Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Tacrolimus
FDA approved
Fludarabine
FDA approved
Daratumumab
FDA approved
Cyclophosphamide
FDA approved
Mycophenolate mofetil
FDA approved
Mechlorethamine
FDA approved

Find a Location

Who is running the clinical trial?

Srinivas DevarakondaLead Sponsor
Srinivas Devarakonda, M.D.Principal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center

Frequently Asked Questions

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

Who meets the requisite criteria for inclusion in this experiment?

"This clinical trial is searching for 20 people with multiple myeloma, aged between 18 and 75. Successful applicants will be selected for the study."

Answered by AI

Does the trial permit elderly individuals to participate?

"According to the specified criteria, all potential participants must be within 18 and 75 years of age. Additionally, there are 383 trials dedicated to minors and 1694 clinical studies intended for seniors."

Answered by AI

What prior investigations have been conducted in regards to Allogeneic Hematopoietic Stem Cell Transplantation?

"Currently, 1143 clinical trials dedicated to Allogeneic Hematopoietic Stem Cell Transplantation are ongoing with 209 in Phase 3. Philadelphia, Pennsylvania is the hub of this research but there are many other locations around the world hosting similar studies - 35293 sites altogether."

Answered by AI

How many people have opted to participate in this experiment?

"Correct. According to clinicaltrials.gov, this study is presently recruiting volunteers and has been doing so since its original posting date of May 27th 2020; the most recent edit was made on March 18th 2021. Twenty individuals are needed for enrolment at a single medical centre."

Answered by AI

Are there any vacancies for individuals in this clinical exploration?

"Affirmative. Clinicaltrials.gov indicates that this research, which was initially posted on May 27th 2020, is currently recruiting patients. Approximately 20 participants are needed to be enrolled at a single facility."

Answered by AI

What medical condition are Allogeneic Hematopoietic Stem Cell Transplantations primarily used to treat?

"Allogenic Hematopoietic Stem Cell Transplantation is a viable therapeutic option for multiple skin-related disorders such as dermatitis, atopic conditions. Additionally, it can be used to treat various types of leukemia and lymphoma, in addition to autoimmune diseases like Multiple sclerosis."

Answered by AI

How secure is Allogeneic Hematopoietic Stem Cell Transplantation for patients?

"Allogeneic Hematopoietic Stem Cell Transplantation is thought to be relatively safe as it has been tested through Phase 2 trials; however, there is yet to be any efficacy data collected. Thus, our team at Power assigned this procedure a score of 2 out of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma
Srinivas Devarakonda 2020. "Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205240.
~0 spots leftby Apr 2025
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