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MyelomaPhase 2NCT00871013

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

A Phase 2 study testing Melphalan, Velcade and Thalidomide in people with Myeloma, run by University of Arkansas at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myeloma
What is being tested?
Melphalan, Velcade and Thalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
Mar 2009to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with symptomatic multiple myeloma (MM), with at least one prior line of chemotherapy or newly diagnosed without any prior therapy.
  • Zebroid ≤ 2, unless solely due to symptoms of MM-related bone disease (Appendix 4).
  • 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.
  • Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.
  • Patients must have adequate pulmonary function studies ≥ 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) ≥ 50% of predicted, within 60 days prior to enrollment. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.
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  • Ejection fraction by ECHO or MUGA must be ≥ 40% and must be performed within 60 days prior to enrollment, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated.
  • Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds five years.
  • Patients must be able to receive full doses of Mel-VRD-PACE, in the opinion of the treating investigator, with the exception that patients with creatinine clearance 30-50 ml/min will receive only 50% of the cisplatin dose.

Who cannot join

  • Fever or active infection requiring intravenous antibiotic, defined as fever or antibiotics within 72 hours from registration.
  • Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of < 30ml/min.
  • Significant neurotoxicity, defined as grade ≥ 3 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
  • Platelet count < 30,000/mm3, and ANC < 1,000/μl
  • POEMS Syndrome: (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes
  • Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
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  • New York Heart Association (NYHA) Class III or Class IV heart failure (Appendix 4).
  • Recent (≤ 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible.
  • Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
  • Poorly-controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
  • Prior cumulative total of Adriamycin exposure >450 mg/m2.
  • Prior exposure to thalidomide which resulted in severe toxicity requiring drug discontinuation.
  • Prior exposure to Revlimid which resulted in severe toxicity requiring drug discontinuation
  • Hypersensitivity to boron, or Mannitol. Prior exposure to bortezomib which resulted in severe toxicity requiring drug discontinuation.
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: UARK 2008-03 Phase II Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (No Prior Transplant)

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy.

Past studies conducted at the MIRT have shown that participants presenting to MIRT who have already received treatment for myeloma tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT with untreated myeloma. Researchers at MIRT think that one reason for this is may be that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.

Read the detailed description
  • To find out if giving multi-agent chemotherapy in lower and more frequent doses to make the timely delivery of chemotherapy cycles possible, will result in better myeloma responses
  • To find out if changing the way the drugs are given during the transplant phase will also result in fewer side effects, while still being effective
  • To find out if giving treatment between transplants (called "inter-therapy") will prevent the myeloma from re-growing between transplants
  • To find out if long-term maintenance therapy will result in longer remissions
  • To find out what the effects (good and bad) of this overall treatment will be
  • To learn more about the biology and genetics of multiple myeloma by performing imaging tests and collecting blood, bone marrow aspirate and biopsies, and biopsies of lesions seen on MRI or PET scans. Bone marrow aspirates and biopsies are tissue sample collected from the bone cavity.
Conditions
Myeloma
Keywords
improve remission rate & survival time in high-risk myeloma
Medical subject headings
Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelphalanDrug

    Also called Alkeran

    Given by vein, Day 3

    First Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4

    Second Inter-Therapy Treatment Bortezomib (Velcade) By vein Days 1 and 4

    Second Transplant Bortezomib (Velcade) By vein Day -5 and Day -2

    Year 1 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 28 days

    Years 2 \& 3 Maintenance Velcade (bortezomib) By vein Days 1, 8, 15, 22(weekly) Every 56 days

  • VelcadeDrug

    Also called Bortezomib, PS-341

    Given by vein, Days 1, 5, 8, 11

  • ThalidomideDrug

    Also called Thalomid

    Given by mouth at bedtime, Days 5-8

  • DexamethasoneDrug

    Also called Decadron

    Given by mouth, once per day Days 5-8

  • CisplatinDrug

    Also called Platinol, CDDP

    Given by vein, Days 5-8 continuous infusion

  • AdriamycinDrug

    Also called Doxorubicin

    Given by vein, days 5-8 continuous infusion

  • CyclophosphamideDrug

    Also called Cytoxan

    Given by vein days 5-8 continuous infusion

  • EtoposideDrug

    Also called Vepesid, VP-16

    Given by vein days 5-8 continuous infusion

Study groups in NCT00871013
Study groupRoleWhat they receive
MEL-VTD-PACEExperimentalMelphalan, Velcade, Thalidomide, Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, Etoposide
Receives: Drug: Melphalan; Drug: Velcade; Drug: Thalidomide; Drug: Dexamethasone; Drug: Cisplatin; Drug: Adriamycin; Drug: Cyclophosphamide; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. .

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00871013
Sponsor's protocol ID
108053
Status last verified
May 2026
First submitted
27 Mar 2009
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Davies FE, Rosenthal A, Rasche L, Petty NM, McDonald JE, Ntambi JA, Steward DM, Panozzo SB, van Rhee F, Zangari M, Schinke CD, Thanendrarajan S, Walker B, Weinhold N, Barlogie B, Hoering A, Morgan GJ. Treatment to suppression of focal lesions on positron emission tomography-computed tomography is a therapeutic goal in newly diagnosed multiple myeloma. Haematologica. 2018 Jun;103(6):1047-1053. doi: 10.3324/haematol.2017.177139. Epub 2018 Mar 22.

    PubMed 29567784

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melphalan, Velcade and Thalidomide in people with Myeloma, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. . (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00871013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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