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Safety and Efficacy Study of High Dose Melphalan HCL for Injection (Propylene Glycol-Free) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Clinipace LTD
Kansas City Bioanalytical Laboratories
Beckloff Associates, Inc.
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01660633
First received: August 2, 2012
Last updated: February 11, 2014
Last verified: February 2014

August 2, 2012
February 11, 2014
December 2012
March 2014   (final data collection date for primary outcome measure)
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Day +100 ] [ Designated as safety issue: Yes ]
  • Mucositis Severity according to World Health Organization Scoring System [ Time Frame: Until Day +30 ] [ Designated as safety issue: Yes ]
  • Mouth Pain Scores according to a Visual Analog Scale [ Time Frame: Until Day +30 ] [ Designated as safety issue: Yes ]
  • Treatment Related Mortality [ Time Frame: Up to Day +100 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01660633 on ClinicalTrials.gov Archive Site
  • MM response according to International Myeloma Working Group (IMWG) criteria. [ Time Frame: At the Day +100 visit ] [ Designated as safety issue: No ]
  • Myeloablation [ Time Frame: Up to Day +30 ] [ Designated as safety issue: No ]
    Absolute neutrophil count (ANC) <0.5 × 109/L, absolute lymphocyte count (ALC) <0.1 × 109/L, platelet count <20,000/mm3, or bleeding requiring transfusion.
  • Neutrophil engraftment [ Time Frame: Up to Day +100 ] [ Designated as safety issue: No ]
    ANC >0.5 × 109/L × first 3 consecutive daily assessments
  • Platelet engraftment [ Time Frame: Up to Day +100 ] [ Designated as safety issue: No ]
    Untransfused platelet measurement >20,000/mm3 × first 3 consecutive daily assessments
  • Non-engraftment [ Time Frame: Up to Day +100 ] [ Designated as safety issue: No ]
    Failure to reach an ANC >0.5 × 109/L × 3 consecutive daily assessments by Day +100.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of High Dose Melphalan HCL for Injection (Propylene Glycol-Free) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation
A Phase IIb, Multicenter, Open-Label, Safety and Efficacy Study of High Dose Melphalan HCL for Injection (Propylene Glycol-Free)for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple myeloma patients (MM) undergoing autologous transplantation.

The sponsor of the current study, Ligand Pharmaceuticals Inc. (Ligand), previously CyDex Pharmaceuticals, Inc. (CyDex), is developing Melphalan HCL for Injection (Propylene Glycol-Free) as an orphan drug product for use as a high dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation. This new injectable form of melphalan HCL incorporates Captisol®, β cyclodextrin sulfobutyl ether sodium salts (also known as [SBE]7m-β-CD), into the product. Captisol is present to facilitate the use of an all aqueous diluent (normal saline) for reconstitution and administration of the freeze-dried product in place of the propylene glycol-ethanol diluent necessary for the currently used melphalan intravenous product. Captisol provides for solubilization and improved stability of the all aqueous reconstituted and diluted infusion solution.

This is the second of two studies supporting product registration. This study will be a multicenter study of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) conducted in 60 patients who have symptomatic MM and qualify for autologous stem cell transplantation (ASCT).

During the Study Period, patients will receive 100mg/m2 of either Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and on Day -2 for a total dose of 200mg/m2. Blood samples (5 timepoints post infusion) for population pharmacokinetic (PK) evaluation will be withdrawn through an indwelling i.v. cannula on the first day of administration of melphalan (Day -3) for all patients and then additional blood samples (2 timepoints post infusion) drawn in a subset of patients on the second day of melphalan administration (Day -2).

Following one day of rest after the high dose myeloablative conditioning (Day -1), patients will receive an autologous graft (Day 0).

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)
200 mg melphalan/m2 will be divided into two separate, consecutive doses of 100 mg/m2 administered on day -3 and day -2 prior to ASCT. The High-Dose Melphaln HCL for Injection (Propylene Glycol-Free) will be reconstituted to 5 mg/mL (also containing 270 mg/mL of Captisol®). The Melphalan HCL for Injection (Propylene Glycol Free) will be further diluted with normal saline to a concentration of no greater than 0.45 mg/mL and infused over 30 minutes ( + or - 3 minutes)via a central venous catheter.
High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)
Subjects will receive only High-Dose Melphalan HCL for Injection (Propylene Glycol-free) at 200mg/m2 (100mg/m2/day for two days).
Intervention: Drug: High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with symptomatic MM based on IMWG guidelines requiring treatment who are eligible for ASCT.
  • Patients who are 70 years of age or younger at time of transplant. Patients older than 70 years of age may be enrolled on a case-by-case basis if the patient meets local institutional criteria to receive a total melphalan dose of 200 mg/m2 as a conditioning regimen and if approved by the medical monitor.
  • Patients with an adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 × 106 CD34+ cells/kg based on patient body weight.

Patients with adequate organ function as measured by:

  • Cardiac function: Left ventricular ejection fraction at rest >40% (documented within 8 weeks prior to Day -3).
  • Hepatic function: Bilirubin <2 × the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <3 × upper limit of normal.
  • Renal function: Creatinine clearance >40 mL/minute (measured or calculated/estimated).
  • Pulmonary function: Carbon monoxide diffusing capacity (DLCO)corrected for hemoglobin (Hgb), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC), and oxygen saturation >92% on room air (documented within 4 weeks prior to Day -3).
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

  • Patients with smoldering MM not requiring therapy.
  • Patients with plasma cell leukemia.
  • Patients with systemic amyloid light chain amyloidosis.
  • Patients with uncontrolled hypertension.
  • Patients with an active bacterial, viral, or fungal infection.
  • Patients with a life expectancy of < 6 months.
  • Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent >5 years previously will be allowed. Cancer treated with curative intent <5 years previously will not be allowed unless approved by the medical monitor.
  • Female patients who are pregnant or breastfeeding.
  • Female patients of childbearing potential who are unwilling to use adequate contraceptive techniques during and for 3 months following study treatment with Melphalan HCl for Injection (Propylene Glycol-Free).
  • Patients seropositive for Human Immunodeficiency Virus(HIV).
  • Patients who are unwilling to provide informed consent.
  • Patients receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 30 days prior to the ASCT or planning to receive any of these treatments prior to Day +30.
  • Patients concurrently participating in any other clinical study involving ASCT.
  • Patients who are hypersensitive or intolerant to any component of the study drug formulation.
Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01660633
CDX-353-002
Yes
Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
  • Clinipace LTD
  • Kansas City Bioanalytical Laboratories
  • Beckloff Associates, Inc.
Study Director: Tim Freeman Clinipace Worldwide
Spectrum Pharmaceuticals, Inc
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP