Anti-Thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00635024

Purpose

RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing.

Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: anti-thymocyte globulin Drug: melphalan	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

The proportion of confirmed response (complete response, partial response, or very good partial response) during first 4 months of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	May 2008
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.

Secondary

To assess the toxicity and tolerability of this combination in these patients.
To assess time to disease progression in patients treated with these drugs.
To assess survival of patients treated with these drugs.

OUTLINE: Patients receive anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats every 28 days for 6 courses. Patients then receive melphalan alone as above for another 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma
- Relapsed disease
Must not be a candidate for stem cell transplantation, has refused transplantation, or has had stem cells collected previously
Measurable disease, defined by ≥ 1 of the following:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- More than 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

PATIENT CHARACTERISTICS:

ECOG performance status 0-3
Absolute neutrophil count ≥ 1,000/μL
Platelet count ≥ 75,000/μL
Hemoglobin ≥ 8.0 g/dL
CD4 > 100/μL
Creatinine ≤ 3 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active malignancy with the exception of nonmelanoma skin cancer or in situ cervical or breast cancer
No uncontrolled infection
No other co-morbidity that would interfere with patient's ability to participate in trial

PRIOR CONCURRENT THERAPY:

No limit to prior therapy
At least 4 weeks since prior melphalan or other myelosuppressive agents
At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
No concurrent high-dose corticosteroids
- Concurrent chronic steroids (maximum dose 20 mg/day prednisone equivalent) allowed if they are being given for disorders other than amyloid (e.g., adrenal insufficiency or rheumatoid arthritis)
- Concurrent continuation of low level/stable steroid doses for replacement or inhalation therapy allowed
Concurrent bisphosphonates allowed
No concurrent immunosuppressive medications such as cyclosporine
No other concurrent investigational treatment
No concurrent cytotoxic chemotherapy or external-beam radiotherapy
No other concurrent systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
No concurrent prophylactic hematopoietic growth factors (unless for treatment of an established cytopenia)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635024

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Shaji K. Kumar, MD	Mayo Clinic
Investigator:	Morie A. Gertz, MD	Mayo Clinic
Investigator:	Philip R. Greipp, MD	Mayo Clinic
Investigator:	Thomas E. Witzig, MD	Mayo Clinic
Investigator:	John A. Lust, MD, PhD	Mayo Clinic
Investigator:	Martha Q. Lacy, MD	Mayo Clinic
Investigator:	Angela Dispenzieri, MD	Mayo Clinic
Investigator:	S. V. Rajkumar, MD	Mayo Clinic
Investigator:	Steve Zeldenrust, MD	Mayo Clinic
Investigator:	Suzanne Hayman, MD	Mayo Clinic
Investigator:	Stephen J. Russell, MD, PhD	Mayo Clinic
Investigator:	Francis K. Buadi, MD	Mayo Clinic
Investigator:	David Dingli, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic Cancer Center ( Shaji K. Kumar )
Study ID Numbers:	CDR0000589032, MAYO-MC0687
Study First Received:	March 12, 2008
Last Updated:	April 4, 2009
ClinicalTrials.gov Identifier:	NCT00635024 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:

Melphalan
Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Immunosuppressive Agents
Multiple Myeloma
Antilymphocyte Serum
Hemorrhagic Disorders
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Alkylating Agents
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Melphalan
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Immunosuppressive Agents
Pharmacologic Actions
Multiple Myeloma
Antilymphocyte Serum
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009