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Active, not recruitingNCT00869232Updated May 22, 2026

UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission

A Phase 2 interventional study of Velcade and Melphalan in Multiple Myeloma, sponsored by University of Arkansas. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University of Arkansas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 with standard chemotherapy.

Past studies conducted at the MIRT and at other institutions have shown that participants with high-risk features by gene array studies tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. Researchers at MIRT think that one reason for this is 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 treatment outcomes
  • 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-transplant 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 for research
02

Conditions studied

  • Multiple Myeloma

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Keywords

  • Multiple Myeloma
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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 90 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have newly diagnosed active MM requiring treatment. Patients with previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
  • Patients must be either untreated o have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
  • Patients must have high-risk disease, as defined by any one of the following:
  • GEP risk score of > or = 0.66 or
  • LDH > or = 360 U/L Rule out hemolysis, infection an contact PI for clarification
  • Zubrod \< or = 2, unless solely due to symptoms of MM-related bone disease.
  • Patients must have a platelet count of > or = 50,000/uL, unless lower levels are explained by extensive bone marrow plasmacytosis.
  • Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
  • Participants must have preserved renal function as defined by a serum creatinine level of \< 3 mg/dL.
  • Participants must have an ejection fraction by ECHO or MUGA scan > or = 45%
  • Patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (FEV squared, FVC, etc) and diffusion capacity (DLCO) > or = 50% of predicted. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, exception may be granted if the principle investigator documents that the patient is a candidate for high dose therapy.
  • Patients must have signed an IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.

Exclusion criteria

Exclusion Criteria:

  • Does not have high-risk disease
  • 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.
  • 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.
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    MEL--VTD-PACE

    Melphalan, Velcade, Thalidomide, Dexamethasone, Cisplatin, Adriamycin, Cyclophosphamide and Etoposide

    Drug: Velcade · Drug: Melphalan · Drug: Thalidomide · Drug: Dexamethasone · Drug: Cisplatin · Drug: Adriamycin · Drug: Cyclophosphamide · Drug: Etoposide

Interventions

  • DrugVelcade

    1.0mg/m2 days 1, 5, 8, \& 11

    Also known as: PS-341

  • DrugMelphalan

    10 mg/m2 day 3

    Also known as: Alkeran

  • DrugThalidomide

    200 mg days 5-8

    Also known as: Thalomid

  • DrugDexamethasone

    40 mg day 5-8

    Also known as: Decadron

  • DrugCisplatin

    10 mg/m2 day 5-8

    Also known as: Platinol

  • DrugAdriamycin

    10 mg/m2 day 5-8

    Also known as: Doxorubicin

  • DrugCyclophosphamide

    400 mg/m2 day 5-8

    Also known as: Cytoxan

  • DrugEtoposide

    40 mg/m2 day 5-8

    Also known as: Vp-16, Vepesid

06

What researchers measure

Primary outcomes

  1. Accelerate and sustain, at 2 years from starting therapy

    Time frame: 2 years

Secondary outcomes

  1. 48hrs after melphalan 10mg/m2, gene expression profiling (GEP) examinations of CD138-purified MM plasma cells (PC)and of bone marrow biopsy (BX)samples

    Time frame: 2 years

07

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
08

References and documents

Publications

  • Ling W, Zangari M, Van Rhee F, Barlogie B, Yaccoby S. Altered mesenchymal and endothelial subsets in interstitial bone marrow and focal lesions in myeloma patients and SCID-hu mice. Haematologica. 2025 Nov 1;110(11):2740-2751. doi: 10.3324/haematol.2025.287717. Epub 2025 Jun 12. PubMed 40501401 ↗
  • Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available. PubMed 33357481 ↗
  • 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00869232
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
Mar 25, 2009
Start date
Oct 2008
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
May 22, 2026

Study contacts

Frits van Rhee, MD, PhD
principal investigator · UAMS

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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