High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

NCT00349778 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-0570497115BMT183
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pulmonary Toxicity

  Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.

  2 years

Secondary Outcomes (2)

• Overall Participant Survival (OS)

  5 years

• Number of Participants That Relapse After Autologous Transplantation

  5 years

Study Arms (1)

High-Dose Sequential Therapy

EXPERIMENTAL

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

Drug: Cyclophosphamide; Drug: Etoposide; Drug: Melphalan; Drug: Carmustine; Drug: Filgrastim

Interventions

Cyclophosphamide DRUG

Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in \~250 mL of saline or D5W and infused IV over 2 hours

Also known as: Cytoxan, Neosar

High-Dose Sequential Therapy

Etoposide DRUG

100 mg etoposide as 5 mL solution in clear ampules for injection.

Also known as: Etopophos, VePesid, Toposar, VP-16, Etoposide phosphate

High-Dose Sequential Therapy

Melphalan DRUG

Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.

Also known as: Alkeran, L-PAM, L-Sarcolysin, Phenylalanine mustard

High-Dose Sequential Therapy

Carmustine DRUG

Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.

Also known as: BiCNU, BCNU

High-Dose Sequential Therapy

Filgrastim DRUG

Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.

Also known as: Neupogen, Granulocyte-colony stimulating factor (G-CSF)

High-Dose Sequential Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage II to III multiple myeloma, or progression after initial treatment of Stage I disease; early or relapsed
• Age 18 to 75 years.
• Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
• Patients with amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
• Patients must have a Karnofsky performance status \> 70%.
• Aspartate aminotransferase (AST) must be \< 2 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) must be \< 2 x ULN
• Total bilirubin \< 2 mg/dL.
• Serum creatinine \< 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.
• Patients must be HIV-negative.
• Patients must provide signed, informed consent.

You may not qualify if:

• Severe psychological or medical illness
• Prior autologous hematopoietic cell transplantation
• Pregnant
• Lactating women
• Smoldering multiple myeloma,
• Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Chen AI, Negrin RS, McMillan A, Shizuru JA, Johnston LJ, Lowsky R, Miklos DB, Arai S, Weng WK, Laport GG, Stockerl-Goldstein K. Tandem chemo-mobilization followed by high-dose melphalan and carmustine with single autologous hematopoietic cell transplantation for multiple myeloma. Bone Marrow Transplant. 2012 Apr;47(4):516-21. doi: 10.1038/bmt.2011.106. Epub 2011 May 23.

  PMID: 21602899 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide; Etoposide; etoposide phosphate; Melphalan; Carmustine; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Sally Arai
• Organization: Stanford University

sarai1@stanford.edu

650-723-0822

Study Officials

• Sally Arai

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)