Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma

NCT00635024 | Terminated Phase 2 Results

• 4 other identifiers: CDR0000589032P30CA015083MC068706-005792
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response

  Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.

  4 months

Secondary Outcomes (4)

• Overall Survival (OS)

  up to 2 years

• Progression-free Survival (PFS)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Number of Participants With Severe Non-hematological Adverse Events

  every month during treatment, up to 12 months

Study Arms (1)

Anti-thymocyte Globulin/Melphalan

EXPERIMENTAL

Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)

Biological: anti-thymocyte globulin; Drug: melphalan

Interventions

anti-thymocyte globulin BIOLOGICAL

2.5 mg/kg

Anti-thymocyte Globulin/Melphalan

melphalan DRUG

16 mg/m\^2

Anti-thymocyte Globulin/Melphalan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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: * Eastern Cooperative Oncology Group (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)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Antilymphocyte Serum; Melphalan

Condition Hierarchy (Ancestors)

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)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Limitations and Caveats

After 1 patient was recruited, this trial temporarily closed to allow the first dose of Anti-thymocyte Globulin to be split over two days. Before the modification was written, it was decided to permanently close this study due to competing trials.

Results Point of Contact

• Title: Dr. Shaji Kumar
• Organization: Mayo Clinic

kumar.shaji@mayo.edu

Study Officials

• Shaji K. Kumar, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 13, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: November 1, 2010
• Last Updated: February 10, 2017
• Results First Posted: October 18, 2010

Record last verified: 2011-08

Locations

US (1)