Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma

NCT01453101 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00001261
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Transplant

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.

  Subjects will be followed for progression-free survival for at least 36 months

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to 3 years

• Overall Response Rate

  Up to 3 years

Study Arms (1)

Fludarabine, Melphalan, Bortezomib

OTHER

Drug: Fludarabine monophosphate, melphalan, Bortezomib

Interventions

Fludarabine monophosphate, melphalan, Bortezomib DRUG

* Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5. * Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2 * Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.

Also known as: Fludara, Phenylalanine Mustard, Velcade

Fludarabine, Melphalan, Bortezomib

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of multiple myeloma
• Have a suitable related or unrelated donor
• Age ≥18 but \<70 yrs
• KPS of ≥70%
• Recovery from complications of previous therapies

You may not qualify if:

• Diagnosis other than multiple myeloma
• Chemotherapy or radiotherapy within 21 days of initiating treatment in this study
• Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
• Uncontrolled bacterial, viral, fungal or parasitic infections
• Uncontrolled CNS metastases
• Known amyloid deposition in heart
• Organ dysfunction
• LVEF \<40% or cardiac failure not responsive to therapy
• FVC, FEV1, or DLCO \<50% of predicted and/or receiving supplementary continuous oxygen
• Evidence of hepatic synthetic dysfunction, or total bilirubin \>2x or AST \>3x ULN
• Measured creatinine clearance \<20 ml/min
• Sensory peripheral neuropathy grade 4 within 14 days of enrollment
• Karnofsky score \<70% unless a result of bone disease directly caused by myeloma
• Life expectancy limited by another co-morbid illness
• Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fludarabine phosphate; Melphalan; Bortezomib

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)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Joshua Zenreich
• Organization: Hackensack Meridian Health

joshua.zenreich@hmhn.org

15519964248

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: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 17, 2011
• Study Start: June 9, 2010
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: April 8, 2026
• Results First Posted: May 25, 2022

Record last verified: 2026-03

Locations

US (1)