← Back to Search

Anti-tumor antibiotic

Chemotherapy Regimen for Multiple Myeloma

Phase 2

Waitlist Available

Led By Maurizio Zangari, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be at least 18 years of age and not older than 75 years of age at the time of registration

Patient must not have had a prior auto- or allotransplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial is testing a new chemotherapy regimen for myeloma patients who have already had treatment. Results from past studies conducted at MIRT show that patients treated with this new regimen have longer remissions and better responses to treatment than patients who received standard chemotherapy.

Who is the study for?

This trial is for adults aged 18-75 with symptomatic multiple myeloma, who have had prior chemotherapy or are newly diagnosed. They must have good heart and lung function, no severe past reactions to certain drugs like thalidomide or bortezomib, and no other serious illnesses that could affect the study. Pregnant women can't join, and participants must agree to use contraception.Check my eligibility

What is being tested?

The trial tests a combination of chemotherapy drugs (Adriamycin, Etoposide, Cisplatin, Cyclophosphamide, Dexamethasone, Melphalan, Velcade & Thalidomide) in lower doses but more frequent cycles. The aim is to prevent myeloma cells from regrowing between treatments to achieve longer remission periods.See study design

What are the potential side effects?

Potential side effects include nausea and vomiting from Adriamycin; low blood counts from Etoposide; kidney damage from Cisplatin; hair loss and bladder issues from Cyclophosphamide; weight gain from Dexamethasone; mouth sores from Melphalan; nerve damage from Velcade; and drowsiness or constipation from Thalidomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Select...

I have never had a bone marrow or stem cell transplant.

Select...

My lung function tests are at least half of what's expected, or I've had a CT scan due to chest pain from myeloma.

Select...

I have multiple myeloma and have had at least one chemotherapy treatment or none if newly diagnosed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary objective of this study is to assess the continued complete and near complete response rate (CR/nCR) at two years after initiation of therapy. .

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837

36%

Infection (grade 3 and above)

24%

Graft versus host disease

Renal insufficiency

SupraVentricular Tachycardia

Alerted mental status

Posterior Reversible Encephalopathy Syndrome

Gastrointestinal bleed

Respiratory failure

Hypokalemia

100%

80%

60%

40%

20%

Study treatment Arm

Patients With Sickle Cell Anemia

Trial Design

1Treatment groups

Experimental Treatment

Group I: MEL-VTD-PACEExperimental Treatment8 Interventions

Melphalan, Velcade, Thalidomide, Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, Etoposide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Dexamethasone

2007

Completed Phase 4

~2590

Adriamycin

2015

Completed Phase 4

~5820

Etoposide

2010

Completed Phase 3

~2440

Cyclophosphamide

1995

Completed Phase 3

~3780

Melphalan

2008

Completed Phase 3

~1500

Velcade

2006

Completed Phase 4

~1320

Thalidomide

2001

Completed Phase 4

~3050

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,193 Total Patients Enrolled

55 Trials studying Multiple Myeloma

11,980 Patients Enrolled for Multiple Myeloma

Maurizio Zangari, MDPrincipal InvestigatorUniversity of Arkansas

6 Previous Clinical Trials

454 Total Patients Enrolled

6 Trials studying Multiple Myeloma

454 Patients Enrolled for Multiple Myeloma

Media Library

Adriamycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00871013 — Phase 2

Multiple Myeloma Research Study Groups: MEL-VTD-PACE

Multiple Myeloma Clinical Trial 2023: Adriamycin Highlights & Side Effects. Trial Name: NCT00871013 — Phase 2

Adriamycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00871013 — Phase 2

Frequently Asked Questions

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

How many volunteers is this study recruiting?

"Not at present. This research project initially went live on March 1st 2009 and was last updated in November 2022. Nonetheless, there are currently 104 trials recruiting patients with multiple myeloma and 2190 trials admitting participants for Melphalan therapy."

Answered by AI

To what extent can Melphalan be administered without putting patients at risk?

"Taking into account the Phase 2 trial status, which indicates initial safety data but no efficacy evidence yet, we assigned Melphalan a score of two."

Answered by AI

Is the participation of individuals aged fifty and above accepted in this medical investigation?

"This clinical trial is accessible to individuals aged 18-75. There are 431 studies tailored towards those younger than 18, and 1987 for seniors over 65 years of age."

Answered by AI

Is the recruitment phase of this clinical trial still open?

"This clinical trial is no longer actively enrolling patients. It was initially published on March 1st 2009 and last updated on November 1st 2022. Should you be seeking alternate studies, there are currently 104 trials for multiple myeloma and 2190 trials for Melphalan that are recruiting participants."

Answered by AI

What health conditions is Melphalan most commonly prescribed to treat?

"Melphalan is primarily prescribed to treat Kaposi's Sarcoma, however it can also be utilised in the treatment of Merkel cell carcinoma, Leukemia, and Synovitis."

Answered by AI

Who qualifies for inclusion in this research endeavor?

"This study is actively searching for 160 eligible participants, aged between 18 and 75 years old with a confirmed diagnosis of multiple myeloma. In order to be considered, applicants must not have had any prior malignancy or cancer treatments within the year preceding enrollment as well as having pulmonary function studies ≥ 50% of predicted on mechanical aspects (FEV1, FVC etc) and diffusion capacity (DLCO) ≥50% of predicted. Furthermore, patients need to demonstrate an ejection fraction by ECHO or MUGA test that exceeds 40%, unless they have received chemotherapy in which case the LVEF needs to be retested"

Answered by AI

Does this experimental procedure have any precedent?

"Melphalan has been studied since 1997 when Alfacell sponsored the first clinical trial, which involved 300 participants. After Phase 3 approval was received in 1997, an impressive 2190 active trials have emerged across 86 countries and 4030 cities."

Answered by AI

Recent research and studies

HaematologicaJournal

Treatment to Suppression of Focal Lesions on Positron Emission Tomography-computed Tomography Is a Therapeutic Goal in Newly Diagnosed Multiple Myeloma

Davies, Faith E., Adam Rosenthal, Leo Rasche, Nathan M. Petty, James E. McDonald, James A. Ntambi, Doug M. Steward, et al.. 2018. “Treatment to Suppression of Focal Lesions on Positron Emission Tomography-computed Tomography Is a Therapeutic Goal in Newly Diagnosed Multiple Myeloma”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2017.177139.

clinicaltrials.govStudy

Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy

2009. "Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00871013.

All > Velcade