NCT00005792

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 1998

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

February 2, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
12.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

8.1 years

First QC Date

June 2, 2000

Last Update Submit

November 6, 2019

Conditions

Multiple MyelomaPlasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence of mucositis

    To determine the incidence and duration of CTCAE v3, grade 3 or 4 mucositis for modified dose level four.

    5 years

Study Arms (1)

MTV

EXPERIMENTAL

Melphalan Topotecan Etoposide VP-16 Phosphate autologous stem cell transplant

Drug: etoposide phosphateDrug: melphalanDrug: topotecanProcedure: Autologous Stem Cell Rescue

Interventions

etoposide phosphateDRUG

Etoposide phosphate 1363 mg/m\^2/day IV over 4 hours (total dose 2726 mg/m\^2, or 2400 mg/m\^2 etoposide equivalents), beginning 24 hours after the completion of the last infusion of topotecan Days -4, -3

Also known as: Topotecan
MTV
melphalanDRUG

Melphalan 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2), followed immediately by topotecan. Days -7, -6, -5

Also known as: Alkeran(R)
MTV
topotecanDRUG

Topotecan 3.3 mg/m\^2/day (starting total dose = 10 mg/m\^2 for level 2) IV over 30 minutes. No topotecan will be administered on the first dose level Days -7, -6, -5

MTV
Autologous Stem Cell RescuePROCEDURE

reinfusion of stem cells, Day 0

Also known as: Autologous stem cell transplant
MTV

Eligibility Criteria

Age15 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Newly diagnosed, drug sensitive (i.e., greater than 50% response to standard chemotherapy), and poor prognostic indicators (e.g., Salmon-Durie stage III, serum beta-2-microglobulin greater than 3.0 ug/L, high proliferative fraction, or hypodiploidy) OR Relapsed after a response to standard chemotherapy OR Primary refractory disease No active leptomeningeal involvement History of prior CSF tumor involvement without symptoms or signs allowed provided CSF is now free of disease on lumbar puncture and MRI of brain shows no tumor involvement No severe symptomatic CNS disease of any etiology PATIENT CHARACTERISTICS: Age: 15 to 69 Performance status: ECOG 0-1 ECOG 3-4 secondary to bone pain or a potentially reversible disease related problem eligible at investigator's discretion Life expectancy: At least 12 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal No history of severe hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine at least 40 mL/min No hemodialysis or peritoneal dialysis Cardiovascular: No evidence of severe cardiac dysfunction Ejection fraction at least 50% by MUGA scan No major heart disease Essential hypertension controlled with medications allowed Pulmonary: DLCO at least 50% of normal No symptomatic obstructive or restrictive pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychosocial disorder that would preclude study compliance No active infections No uncontrolled insulin dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No other prior malignancy except for nonmelanoma skin cancer HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior total dose of doxorubicin or daunorubicin greater than 450 mg/m2 No prior topotecan or any other topoisomerase I inhibitor, etoposide, etoposide phosphate, or teniposide Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent nitroglycerin preparations for angina pectoris No concurrent antiarrhythmic drugs for major ventricular dysrhythmias

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

etoposide phosphateTopotecanMelphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Daniel M. Sullivan, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

February 2, 2004

Study Start

June 2, 1998

Primary Completion

July 1, 2006

Study Completion

November 1, 2018

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

US(1)