Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple MyelomaAllogeneic Hematopoietic Stem Cell Transplantation - Procedure
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 2 years post-transplant

Day 365
Rate of minimal residual disease-negativity
Year 1
1-year cumulative incidence TRM
Year 2
2-year cumulative incidence of TRM
Day 100
100-day cumulative incidence of treatment-related mortality (TRM)
Year 2
Overall survival (OS)
Year 2
Rate of relapse
Year 1
1- year GVHD-free Relapse-free Survival (GRFS)
Year 2
2-year progression-free survival (PFS)
Year 2
Best response rate
Incidence of adverse events
Overall response rate
Up to 6 weeks
Cumulative incidence of grade II-IV acute graft-versus host disease (GvHD (aGVHD)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Treatment (Fludarabine, Transplant, Immunosuppression)
5%Febrile neutropenia
5%Hypoxia
5%Acute kidney injury
4%Blood bilirubin increased
4%Creatinine increased
4%Diarrhea
4%Sepsis
3%Bronchopulmonary hemorrhage
3%Chronic kidney disease
3%Hypotension
3%Lung infection
3%Left ventricular systolic dysfunction
3%Thromboembolic event
1%Gastric hemorrhage
1%Atrial fibrillation
1%Atrial flutter
1%Heart failure
1%Mucositis oral
1%Pleural effusion
1%Syncope
1%Multi-organ failure
1%Typhlitis
1%Respiratory failure
1%Treatment related secondary malignancy
1%Fever
1%Ejection fraction decreased
1%Paroxysmal atrial tachycardia
1%Gastritis
1%Hemolytic uremic syndrome
1%Ascites
1%Encephalitis infection
1%Hemolysis
1%Myalgia
1%Small intestine infection
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT01251575) in the Treatment (Fludarabine, Transplant, Immunosuppression) ARM group. Side effects include: Febrile neutropenia with 5%, Hypoxia with 5%, Acute kidney injury with 5%, Blood bilirubin increased with 4%, Creatinine increased with 4%.

Trial Design

1 Treatment Group

Treatment (conditioning regimen, stem cell transplant)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Allogeneic Hematopoietic Stem Cell Transplantation · No Placebo Group · Phase 2

Treatment (conditioning regimen, stem cell transplant)Experimental Group · 7 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation, Tacrolimus, Fludarabine, Daratumumab, Cyclophosphamide, Mycophenolate Mofetil, Melphalan · Intervention Types: Procedure, Drug, Drug, Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1280
Tacrolimus
FDA approved
Fludarabine
FDA approved
Daratumumab
FDA approved
Cyclophosphamide
FDA approved
Mycophenolate mofetil
FDA approved
Mechlorethamine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years post-transplant

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

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an estimated creatinine clearance of greater than 40 mL/minute.
You are a haploidentical, mismatch or matched related or unrelated donor.
You have had a partial response (PR) or better prior to allo-transplantation.
You have relapsed MM with chemo sensitivity disease, with or without prior autologous HSCT.
ALT/AST < 2.5 x the upper normal limit.