TerminatedNCT00574080Updated Nov 20, 2017Results posted

UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide

A Phase 3 interventional study of Interim/Maintenance Dexamethasone and Induction/Consolidation Dexamethasone in Multiple Myeloma, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by University of Arkansas · Phase 3, Interventional, and Treatment

Why this study was terminated

low accrual

Phase: Phase 3
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.

Conditions studied

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 20 is below 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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with symptomatic multiple myeloma, sensitive or refractory to at least one prior line of chemotherapy.
Karnofsky performance score > 60%, unless due to MM.
Patients must be \<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.
Negative serology for HIV.
Baseline biopsies and laboratory studies are to be completed within 35 days of registration, within 60 days for scans and radiological studies; patients must not have a history of severe chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. 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.
Patients with recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible. Ejection fraction by ECHO or MUGA must be > 40% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated.
No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval or if the malignancy is considered much less life threatening than the myeloma.
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.
Patients must be able to receive full doses of D 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.

Exclusion criteria

Exclusion Criteria:

Fever or active infection requiring intravenous antibiotic, defined as fever or antibiotics within 72 hours from baseline.
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 \< 100,000/mm\^3, or ANC \< 1,000/μl
POEMS Syndrome.
Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
New York Hospital Association (NYHA) Class III or Class IV heart failure.
Myocardial infarction within the last 6 months.
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 adriamycin exposure >450 mg/m\^2
Prior exposure to thalidomide which resulted in severe toxicity requiring drug discontinuation.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Arm A
DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
Drug: Interim/Maintenance Dexamethasone · Drug: Induction/Consolidation Dexamethasone · Drug: Induction/Consolidation Cisplatin · Drug: Induction/Consolidation Adriamycin · Drug: InductionConsolidation Cyclophosphamide · Drug: Induction/Consolidation Etoposide · Drug: Induction Pegfilgrastim · Drug: Transplant 1 Dexamethasone · Drug: Transplant 1 Cisplatin · Drug: Transplant 1 Adriamycin · Drug: Transplant 1 Cyclophosphamide · Drug: Transplant 1 Etoposide · Drug: Transplant 1 Melphalan · Drug: Transplant 1 and 2 Pegfilgrastim · Procedure: Autologous Peripheral Blood Stem Cell Transplant (ASCT) · Drug: Transplant 2 Carmustine · Drug: Transplant 2 Etoposide · Drug: Transplant 2 Cytarabine · Drug: Transplant 2 Melphalan · Drug: Transplant 2 Dexamethasone
Experimental
Arm B
DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
Drug: Interim/Maintenance Dexamethasone · Drug: Induction/Consolidation Dexamethasone · Drug: Induction/Consolidation Cisplatin · Drug: Induction/Consolidation Adriamycin · Drug: InductionConsolidation Cyclophosphamide · Drug: Induction/Consolidation Etoposide · Drug: Induction Pegfilgrastim · Drug: Transplant 1 Dexamethasone · Drug: Transplant 1 Cisplatin · Drug: Transplant 1 Adriamycin · Drug: Transplant 1 Cyclophosphamide · Drug: Transplant 1 Etoposide · Drug: Transplant 1 Melphalan · Drug: Transplant 1 and 2 Pegfilgrastim · Procedure: Autologous Peripheral Blood Stem Cell Transplant (ASCT) · Drug: Transplant 2 Carmustine · Drug: Transplant 2 Etoposide · Drug: Transplant 2 Cytarabine · Drug: Transplant 2 Melphalan · Drug: Transplant 2 Dexamethasone · Drug: Transplant 1 and 2 Bortezomib · Drug: Transplant 1 and 2 Thalidomide

Interventions

DrugInterim/Maintenance Dexamethasone
20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance
Also known as: Dex, Dexamethasone acetate
DrugInduction/Consolidation Dexamethasone
40 mg Days 1-4
Also known as: Dex, Dexamethasone acetate
DrugInduction/Consolidation Cisplatin
10 mg/m2 by continuous infusion Days 1-4
DrugInduction/Consolidation Adriamycin
10 mg/m2 by continuous infusion Days 1-4
DrugInductionConsolidation Cyclophosphamide
400 mg/m2 by continuous infusion Days 1-4
DrugInduction/Consolidation Etoposide
40 mg/m2 by continuous infusion Days 1-4
DrugInduction Pegfilgrastim
6 mg Days 6 and 13
DrugTransplant 1 Dexamethasone
20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7
DrugTransplant 1 Cisplatin
20 mg/m2 by continuous infusion Days -3 and -2
DrugTransplant 1 Adriamycin
20 mg/m2 by continuous infusion Days -3 and -2
DrugTransplant 1 Cyclophosphamide
800 mg/m2 by continuous infusion Days -3 and -2
DrugTransplant 1 Etoposide
80 mg/m2 by continuous infusion Days -3 and -2
DrugTransplant 1 Melphalan
50 mg/m2 Days -2 and -1
DrugTransplant 1 and 2 Pegfilgrastim
6 mg Day +6
ProcedureAutologous Peripheral Blood Stem Cell Transplant (ASCT)
Day 0
DrugTransplant 2 Carmustine
300 mg/m2 Day -5
DrugTransplant 2 Etoposide
200 mg/m2 Days -5, -4, -3, -2
DrugTransplant 2 Cytarabine
400 mg/m2 Days -5, -4, -3, -2
Also known as: Ara-C
DrugTransplant 2 Melphalan
140 mg/m2 Day -1
DrugTransplant 2 Dexamethasone
20 mg Days -5, -4, -3, -2, +4, +5, +6, +7
DrugTransplant 1 and 2 Bortezomib
1 mg/m2 Days -4, -1, +3, +7
Also known as: Velcade
DrugTransplant 1 and 2 Thalidomide
200 mg Days -4 to +5

What researchers measure

Primary outcomes

Event Free Survival
Time from study registration until disease progression or death.
Time frame: Up to 3 years 8 months

Results

Posted Jun 30, 2011

Limitations and caveats

Early termination led to small numbers of subjects to be analyzed. Less than 10% of the target accrual were enrolled before termination of study.

Participant flow

Participants are myeloma patients who have already received one or more treatment regimens and are seen at our facility

Participant flow — Overall Study
Milestone	VTD + DPACE/Melphalan	DPACE/Melphalan
Started	10	10
Completed	0	0
Not completed	10	10
Withdrew: Death	10	10

Outcome measures

PrimaryEvent Free Survival

Time from study registration until disease progression or death.

Time frame:: Up to 3 years 8 months

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
VTD + DPACE/Melphalan	—	4/10 (40%)	0/10 (0%)
DPACE/Melphalan	—	3/10 (30%)	0/10 (0%)

Most frequent serious events

Most frequent serious events
Event	VTD + DPACE/Melphalan	DPACE/Melphalan
deathGeneral disorders	2/10	0/10
embolusBlood and lymphatic system disorders	0/10	1/10
deathGeneral disorders	1/10	0/10
deathCardiac disorders	0/10	1/10
deathNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/10	1/10
deathGeneral disorders	0/10	1/10
deathGeneral disorders	1/10	0/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	VTD + DPACE/Melphalan	DPACE/Melphalan	Total
<=18 years	0	0	0
Between 18 and 65 years	10	6	16
>=65 years	0	4	4

Age, Continuous
Age, Continuous(years)	VTD + DPACE/Melphalan	DPACE/Melphalan	Total
Mean	56.2 ± 5.01	59 ± 8.67	57.6 ± 7.04

Sex: Female, Male
Sex: Female, Male(Participants)	VTD + DPACE/Melphalan	DPACE/Melphalan	Total
Female	6	5	11
Male	4	5	9

Region of Enrollment
Region of Enrollment(participants)	VTD + DPACE/Melphalan	DPACE/Melphalan	Total
United States	10	10	20

Study locations

1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00574080
Lead sponsor: University of Arkansas
Responsible party: Sponsor
First posted: Dec 14, 2007
Start date: Jul 2006
Primary completion: Mar 2011
Completion: Mar 2011
Results posted: Jun 30, 2011
Last update: Nov 20, 2017

Study contacts

Frits van Rhee, MD, PhD

principal investigator · University of Arkansas

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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