Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT00028600 | Completed Phase 2

• 3 other identifiers: CALGB-100001U10CA031946CDR0000069109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 15

Brief Summary

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

Conditions

Multiple Myeloma; Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment-related mortality

  6 months

Secondary Outcomes (6)

• Treatment Completion Rate

  post treatment

• Respone Rate

  2-4 wks prior, and 3,6 mon then q 3 mon for 3 yrs, post allo transpl, then q 6 mon for max 15 yrs from study entry

• Chimerism Rate

  1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI

• GVHD Incidence

  post allo transpl, & pre & post DLI

• Survival

  2 years

Study Arms (1)

Autologous + Allogeneic Transplant

EXPERIMENTAL

autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma

Biological: filgrastim; Biological: CD34+ cells; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: melphalan; Drug: methotrexate; Drug: tacrolimus

Interventions

filgrastim BIOLOGICAL

PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC \>= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC \> 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2

Also known as: G-CSF

Autologous + Allogeneic Transplant

CD34+ cells BIOLOGICAL

2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant

Autologous + Allogeneic Transplant

cyclophosphamide DRUG

4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep

Autologous + Allogeneic Transplant

fludarabine phosphate DRUG

30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl

Autologous + Allogeneic Transplant

melphalan DRUG

200mg/sq m IV infusion over 15-30 min D 2 auto transpl

Autologous + Allogeneic Transplant

methotrexate DRUG

5mg/sq m/d IV infusion D 1,3,\& 6: allo transpl

Autologous + Allogeneic Transplant

tacrolimus DRUG

0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150

Autologous + Allogeneic Transplant

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of active multiple myeloma that requires treatment * Durie-Salmon stage I, II, and III * No more than 1 progression after initial therapy * Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR) * No syngeneic donors * Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia) PATIENT CHARACTERISTICS: Age: * Under 65 Performance status: * NCI CTC 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 500/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin less than 2 mg/dL * AST less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN Renal: * Creatinine less than 2 mg/dL * Creatinine clearance greater than 40 mL/min Cardiovascular: * LVEF at least 30% by MUGA scan Pulmonary: * DLCO greater than 40% of predicted * No symptomatic pulmonary disease Other: * HIV negative * No uncontrolled diabetes mellitus * No active serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy * Prior alkylating-agent therapy allowed if no more than 12 months duration Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior surgery Other: * All prior therapy no more than 18 months duration

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

Related Publications (1)

• Holstein SA, Suman VJ, Owzar K, Santo K, Benson DM Jr, Shea TC, Martin T, Silverman M, Isola L, Vij R, Cheson BD, Linker C, Anderson KC, Richardson PG, McCarthy PL. Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma. Biol Blood Marrow Transplant. 2020 Aug;26(8):1414-1424. doi: 10.1016/j.bbmt.2020.03.028. Epub 2020 Apr 20.

  PMID: 32325171 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; betibeglogene autotemcel; Cyclophosphamide; fludarabine phosphate; Melphalan; Methotrexate; Tacrolimus

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)

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Lactones

Study Officials

• Kenneth C. Anderson, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Primary Completion: June 1, 2006
• Study Completion: February 1, 2010
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

US (15)