Clinical Trials Logo
NCT number NCT01453088
Study type Interventional
Source Hackensack University Medical Center
Contact Michele Donato, MD
Phone 201-996-5900
Email Michele.Donato@HackensackMeridian.org
Status Recruiting
Phase Phase 2
Start date June 24, 2010
Completion date March 2018

Clinical Trial Summary

In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.


Clinical Trial Description

In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.

Conditioning Regimens:

Treatment arm A Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.

Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.

Dosing will be based on body surface area calculated using actual body weight

Stem cell infusion:

Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures.

Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).

Treatment arm B

Bortezomib:

Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.

Dosing will be based on actual body weight. Dexamethasone is administered at a dose of 20 mg IV prior to each bortezomib infusion.

Melphalan:

Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.

Melphalan will be given as a single dose (not split over 2 or more days) and given of day-2.

Dosing will be based body surface area calculated using actual body weight

Stem cell infusion:

Stem cell infusion will occur on day 0 and will be at least 18 hours after the infusion of the bortezomib. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures.

Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).

Post-transplant Supportive Care will be administered in accordance to the Blood and Marrow Transplant program standard operating procedures.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Recruiting NCT02976493 - Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma N/A
Recruiting NCT02918331 - A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation Phase 1
Recruiting NCT02811978 - Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma Phase 3
Recruiting NCT02852837 - Dose Escalation Study of JNJ-54767414 (Daratumumab) in Chinese Participants With Relapsed or Refractory Multiple Myeloma Who Failed at Least 2 Prior Lines of Systemic Therapy Phase 1
Active, not recruiting NCT00729118 - Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1
Recruiting NCT03290950 - A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma Phase 2
Not yet recruiting NCT03288974 - Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea N/A
Recruiting NCT02902900 - An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice N/A
Completed NCT01830816 - Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Patients With Normal Renal Function or Severe Renal Impairment Phase 1
Active, not recruiting NCT02849444 - A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance N/A
Not yet recruiting NCT03218163 - MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Multiple Myeloma Phase 2
Not yet recruiting NCT03215030 - A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 in Participants With Refractory Multiple Myeloma Phase 1/Phase 2
Recruiting NCT02843074 - Elotuzumab, Lenalidomide and Dexamethasone (ERd) in the Induction, Consolidation and Maintenance Treatment of Transplant-Eligible, Newly Diagnosed Multiple Myeloma Patients Phase 2
Not yet recruiting NCT02786485 - Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT Phase 1
Not yet recruiting NCT03297606 - Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) Phase 2
Recruiting NCT03196414 - Study of CART-138/BCMA Therapy for R/R Multiple Myeloma Phase 1/Phase 2
Recruiting NCT02916420 - Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma Phase 3
Recruiting NCT02897830 - Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Plus Lenalidomide Maintenance in Multiple Myeloma Phase 2