HD Melphalan and SCT in Patients With IGDD or LCDD

NCT00681044 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000595782BHO-H-25876BUMC-H-25876
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.

Conditions

Multiple Myeloma

Keywords

monoclonal immunoglobulin deposition disease; light chain deposition disease

Outcome Measures

Primary Outcomes (1)

• Hematologic Response Rate

  one year

Secondary Outcomes (4)

• Predictability of Early Free Light-chain Response for Heme Response

  One month

• Organ or Clinical Response

  One year

• Overall Survival

  life

• Tolerability

  100 days

Study Arms (1)

SCT with melphalan conditioning

EXPERIMENTAL

Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion

Biological: filgrastim; Drug: melphalan; Procedure: Stem Cell Infusion

Interventions

filgrastim BIOLOGICAL

16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC

Also known as: G-CSF, neulasta

SCT with melphalan conditioning

melphalan DRUG

70-100 mg/m2/day will be administered intravenously on Days -3 and -2

Also known as: alkeran

SCT with melphalan conditioning

Stem Cell Infusion PROCEDURE

infusion of previously collected stem cells on Day 0

SCT with melphalan conditioning

Eligibility Criteria

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

You may qualify if:

• DISEASE CHARACTERISTICS:
• Histologically confirmed light-chain deposition disease based on the following criteria:
• Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red
• Evidence of a plasma cell dyscrasia, as defined by any of the following:
• Monoclonal gammopathy in the serum or urine by immunofixation electrophoresis
• Clonal plasmacytosis on bone marrow biopsy by immuno-histochemical
• Elevated serum levels of FLC
• Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10\^6 cells available for transplantation)
• PRIOR CONCURRENT THERAPY:
• Prior chemotherapy with alkylating agent allowed provided there is no evidence of myelodysplastic syndromes
• Prior total dose of melphalan \< 300 mg
• More than 4 weeks since prior cytotoxic therapy and recovered
• PATIENT CHARACTERISTICS:
• Performance status 0-2
• Left Ventricular Ejection Fraction (LVEF) ≥ 45% within the past 90 days

You may not qualify if:

• No overt multiple myeloma, as defined by any of the following:
• Greater than 30% bone marrow plasmacytosis
• Extensive (i.e., \> 2) lytic lesions
• Hypercalcemia
• No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months
• No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete response, or any other cancer from which the patient has been disease-free for the past 5 years
• No HIV positivity

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; pegfilgrastim; Melphalan

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; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Results Point of Contact

• Title: Dr. Vaishali Sanchorawala, Director of Stem Cell Transplant Program
• Organization: Boston Medical Center

vaishali.sanchorawala@bmc.org

617-637-7017

Study Officials

• Vaishali Sanchorawala, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2008
• First Posted: May 20, 2008
• Study Start: October 1, 2006
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 28, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)