TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma

NCT01039025 | Completed Phase 2

• 1 other identifier: DM01-331
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma.

Conditions

Myeloma

Keywords

Myeloma; Topotecan; Hycamtin; Melphalan; Alkeran; Cyclophosphamide; Cytoxan; Neosar; Stem Cell Harvest; Peripheral Blood Stem Cells

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Within 180 days after treatment

Study Arms (1)

TMC

EXPERIMENTAL

Topotecan, Melphalan, and Cyclophosphamide

Drug: Topotecan; Drug: Cyclophosphamide; Drug: Melphalan; Other: Peripheral Blood Stem Cells

Interventions

Topotecan DRUG

After stem cells are collected, Topotecan 3.5 mg/m\^2 intravenously given over 30 minutes on Days 1 - 5.

Also known as: Hycamtin

TMC

Cyclophosphamide DRUG

After stem cells are collected, Cyclophosphamide 1 g/m\^2/day intravenously given over 2 hours on Days 1 - 3.

Also known as: Cytoxan, Neosar

TMC

Melphalan DRUG

After stem cells are collected, Melphalan 70 mg/m\^2/day intravenously given on Days 4 and 5.

Also known as: Alkeran

TMC

Peripheral Blood Stem Cells OTHER

On Day 7, some or all of the stem cells will be reinfused.

TMC

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intermediate or high tumor mass multiple myeloma with responsive or primary refractory disease; and patients with responsive or refractory relapse.
• Physiological age \</= 70.
• Zubrod performance status \< 3.
• Life expectancy greater than 12 weeks.
• Left ventricular ejection fraction \>/= 50%.
• No uncontrolled arrythmias or symptomatic cardiac disease.
• FEV1, FVC and DLCO \>/= 50%.
• No symptomatic pulmonary disease.
• Serum creatinine \< 1.5 mg/dL.
• Serum bilirubin \< 2x upper limit of normal.
• No evidence of chronic or active hepatitis or cirrhosis.
• Patient is not pregnant.
• Patients or guardian able to sign informed consent.
• No active CNS disease.
• Platelet count \> 100K.

You may not qualify if:

• \) N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• SmithKline Beecham: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center clinical trials web site

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Topotecan; Cyclophosphamide; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michelle Donato, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: February 18, 2002
• Primary Completion: May 19, 2006
• Study Completion: May 19, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)