← Back to Search

Cancer Vaccine

Melphalan for Multiple Myeloma

Phase 2

Waitlist Available

Led By Muhamed Baljevic, MD

Research Sponsored by University of Nebraska

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 will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-transplant

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

Number of Safely Treated Participants (Feasibility and Safety)

Secondary outcome measures

Progression-free survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (vaccine, CD34 transplant, DLI)Experimental Treatment5 Interventions

ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.

Group II: Arm II (vaccine, stem cell transplant)Active Control3 Interventions

Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

T Cell-Depleted Hematopoietic Stem Cell Transplantation

2014

Completed Phase 2

~40

Tetanus Toxoid Vaccine

2016

N/A

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,726 Total Patients Enrolled

9 Trials studying Multiple Myeloma

1,000,354 Patients Enrolled for Multiple Myeloma

Muhamed Baljevic, MDPrincipal InvestigatorUniversity of Nebraska

1 Previous Clinical Trials

11 Total Patients Enrolled

1 Trials studying Multiple Myeloma

11 Patients Enrolled for Multiple Myeloma

Christopher D'Angelo, MDPrincipal InvestigatorUniversity of Nebraska

2 Previous Clinical Trials

63 Total Patients Enrolled

1 Trials studying Multiple Myeloma

30 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Is there an age limit for enlisting in this experiment?

"According to the trial's inclusion criteria, participants must be aged 18-70. There are 108 studies that accept individuals younger than 18 and 892 for adults older than 65 years old."

Answered by AI

Are there currently any open enrolment opportunities for this clinical trial?

"According to data hosted on clinicaltrials.gov, this particular medical trial is not currently recruiting patients. Initially posted on May 1st 2016 and last updated November 21st 2022, no additional participants are being sought out at the moment; however, there are 953 other trials actively looking for volunteers."

Answered by AI

What is the enrollment limit for this clinical research?

"Registration for this trial is no longer available, as the last update was posted November 21st 2021. However, 818 studies targeting multiple myeloma and 135 trials researching T Cell-Depleted Hematopoietic Stem Cell Transplantation are actively looking to bring on new participants."

Answered by AI

Has the FDA given its seal of approval to T Cell-Depleted Hematopoietic Stem Cell Transplantation?

"The safety of T Cell-Depleted Hematopoietic Stem Cell Transplantation is believed to be a 2, as there are no proof points regarding efficacy but some research indicating safety."

Answered by AI

What characteristics do individuals need to possess in order to be eligible for this clinical experiment?

"This clinical trial requires 26 individuals with standard risk multiple myeloma aged 19 to 70. To be eligible, patients must fulfill the following criteria: measurable levels of serum monoclonal protein ≥1.0 g/dL or urine monoclonal protein ≥200 mg/24 hrs and involved free light chain ≥ 10 mg/dL; prior exposure to bortezomib, lenalidomide and dexamethasone (VRd) as a form of induction therapy pre-AHSCT; ability to comprehend information in order sign consent forms; creatinine clearance equal or > 60 ml/min; ejection"

Answered by AI

What illnesses is T Cell-Depleted Hematopoietic Stem Cell Transplantation usually employed to address?

"T Cell-Depleted Hematopoietic Stem Cell Transplantation is a procedure commonly used to treat severe hodgkin lymphoma. It may also be employed for active booster immunization, diphtheria, or tetanus vaccination."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation

Christopher Dangelo 2020. "Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02700841.