Know Cancer

or
forgot password

Phase I/II Study of Liposomal Doxorubicin (Doxil®)/Melphalan/Bortezomib (Velcade®) in Relapsed/Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Phase I/II Study of Liposomal Doxorubicin (Doxil®)/Melphalan/Bortezomib (Velcade®) in Relapsed/Refractory Multiple Myeloma


Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2

Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2

Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2

Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2

Adjunctive therapy with a bisphosphonate, either pamidronate or zolendronic acid, will be
given monthly.

Dose Escalation Schedule: Dose escalation will occur only after patients have completed at
least two cycles at a given dose level.

1. If 0/3 experience DLT (as defined in attachment Section 6.0), the next three patients
will be escalated by one dose level.

2. If 1/3 experience DLT, 3 additional patients enrolled at this dose level.

- If 0, 1, or 2 of these additional patients experience DLT (i.e. total 3/6), the
dose will be escalated.

- If 3/3 experience DLT (i.e. total 4/6) then the next lower dose will be considered
the MTD..

3. If 2/3 experience DLT, 3 additional patients enrolled at this dose level.

- If 0 or 1 of these additional patients experience DLT (i.e. total 3/6), the dose
will be escalated.

- If 2 or more/3 experience DLT (i.e. total more than 3/6) then the next lower dose
level is MTD


Inclusion Criteria:



Disease Characteristics:

1. Patient previously diagnosed with MM;

2. Progressive disease. For non-secretory multiple myeloma, progressive disease is
defined as bone marrow biopsy with > 25% increase in plasma cells or an absolute
increase of at least 10% over prior known level. Alternatively, development of new or
worsening of existing lytic bone lesions or soft tissue plasmacytomas, or
hypercalcemia (serum calcium >11.5 mg/dL), or relapse from CR.

Patient Characteristics:

1. 18 yrs or older

2. Patient has given voluntary written informed consent.

3. Unless post-menopausal or surgically sterilized, a female must be willing to use an
acceptable method of birth control

4. Male patient must agree to use an acceptable method for contraception for the
duration of the study.

5. ECOG Performance Status 0-2.

6. Life expectancy is at least 3 months.

7. • ANC over 1,000/ul without the use of colony stimulating factors

- Platelets over 50,000/ul without transfusion support 7 days

- Bilirubin 2.0 mg/dl or less

- AST 4 times or less upper limit normal Prior Therapy for Multiple Myeloma:
Patients must have had at least 2 prior therapeutic regimens

Exclusion Criteria:

- Pregnant or breast feeding

- History of allergic reaction to compounds containing boron or mannitol.

- Active uncontrolled viral (including HIV), bacterial, or fungal infection.

- Grade III or IV toxicity due to previous anti-neoplastic therapy

- More than Grade 2 motor or sensory neuropathy

- MI within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV
heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or
electrocardiographic evidence of acute ischemia.

- For any patients whose lifetime cumulative doxorubicin dose exceeds 400mg/m2,
patients with LVEF less than 35% by MUGA.

- Concurrent administration of liposomal doxorubicin, melphalan, and bortezomib (single
or two drug combinations of these are permissible)

- Less than 3 weeks since most recent chemotherapy or concurrent chemotherapy

- Use of corticosteroids (mroe than 10 mg prednisone/day or equivalent)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Thomas Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

2408

NCT ID:

NCT00985907

Start Date:

June 2004

Completion Date:

January 2010

Related Keywords:

  • Multiple Myeloma
  • myeloma
  • DMV
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UCSF San Francisco, California  941430324
St. Vincent's Comprehensive Cancer Center New York, New York  10011