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Phase 2
18 Years
Open (Enrolling by invite only)
Multiple Myeloma

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Trial Information

Inclusion Criteria:

Inclusion Criteria - all subjects must:

1. Be at least 18 years of age

2. Subjects must have a documented diagnosis of MM and have either refractory or
relapsed and refractory after first line treatment disease defined as:

- Primary refractory

- Refractory

- Relapsed and Refractory

3. Subjects must have undergone prior treatment with one treatment line of anti-myeloma
therapy. Induction therapy followed by ASCT and consolidation/maintenance will be
considered as one line.Have a confirmed diagnosis of MM

4. Have received lenalidomide after one prior treatment for MM and have reached at least
a partial response (PR), according to IMWG criteria, including two consolidating
cycles. Subjects have experienced a response at least PR after starting treatment
with lenalidomide and cortisone cycles.

5. Have personally signed and dated a legally effective written informed consent form
prior to admission to the study.

6. Must be willing and able to understand and comply with the study requirements.

7. Females of childbearing potential must agree to ongoing pregnancy testing and to
practice contraception.

8. Male must agree to practice contraception

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

- Absolute neutrophil count (ANC) < 1,000/µL

- Platelet count < 75,000/ µL

- Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula

- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

- Serum total bilirubin > 2.0 mg/dL

2. ECOG performance status <4.

3. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM

4. Individuals who have taken any experimental drugs or participated in a clinical trial
within 30 days prior to screening.

5. Individuals with significant psychiatric illness or a clinically significant
acute/chronic uncontrolled medical condition that might affect their experience of
myeloma symptoms or their ability to describe them.

6. Pregnant or lactating females.

7. Any other clinically significant medical disease or condition that, in the
Investigator´s opinion, may interfere with protocol adherence or a subject´s ability
to give informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

24 months

Safety Issue:



Sweden: Regional Ethical Review Board

Study ID:

PI-RV-MM-10-07/ RV-MM-PI 0627



Start Date:

March 2011

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Relapsed and refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell