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Dalteparin, Lenalidomide, and Low-Dose Dexamethasone in Treating Patients With Previously Untreated Multiple Myeloma

This study has been terminated.
(Insufficient Accrual)
National Cancer Institute (NCI)
Celgene Corporation
Information provided by (Responsible Party):
University of Southern California Identifier:
First received: January 18, 2012
Last updated: March 2, 2017
Last verified: March 2017
This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and low-dose dexamethasone together works in treating patients with previously untreated multiple myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with lenalidomide and dexamethasone for multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may be an effective treatment for multiple myeloma

Condition Intervention Phase
Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Drug: dalteparin Drug: lenalidomide Drug: dexamethasone Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Lenalidomide and Low-dose Dexamethasone in Combination With Dalteparin in Previously Untreated Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Number of patients who experienced grade 4 hemorrhage regardless of attribution, or grade 3 hemorrhage that is possibly, probably, or definitely attributable to dalteparin (Arm II) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures:
  • Possible markers of anti-MM effect [ Time Frame: Up to 6 months ]
  • Toxicities observed at each dose level, in terms of type (organ affected, laboratory determination), severity (by Common Toxicity Criteria [CTC]), time of onset, duration, and reversibility or outcome [ Time Frame: Up to 2 years ]
  • Overall response (CR+PR) calculated for each dose level separately [ Time Frame: Up to 2 years ]
  • Time to progression [ Time Frame: Up to 2 years ]
  • Duration of response [ Time Frame: Up to 2 years ]
  • Anti-thrombotic (syndecan-1, TAT, D-dimer, P-selectin) and anti-myeloma (M-spike and IL-6) marker levels [ Time Frame: Up to 2 years ]

Enrollment: 13
Actual Study Start Date: January 9, 2012
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (5000 IU dalteparin)
Patients receive a prophylactic dose of dalteparin SC on days 1-28; lenalidomide PO on days 1-21; and low-dose dexamethasone PO on days 1, 8, 15, and 22.
Drug: dalteparin
Given SC
Other Names:
  • DAL
  • dalteparin sodium
  • Fragmin
Drug: lenalidomide
Given PO
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (200 IU/kg dalteparin)
Patients receive a therapeutic dose of dalteparin SC on days 1-21 and lenalidomide PO and low-dose dexamethasone PO as in Arm I.
Drug: dalteparin
Given SC
Other Names:
  • DAL
  • dalteparin sodium
  • Fragmin
Drug: lenalidomide
Given PO
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Drug: dexamethasone
Given PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


I. To select a dose of Dalteparin to be used with Lenalidomide and low-dose dexamethasone in future trials for patients with previously untreated multiple myeloma (MM), based on toxicity, selected biomarkers (M-spike, interleukin [IL]-6) related to response and other markers of coagulation.


I. To evaluate overall response rate (ORR = complete response [CR] + partial response [PR]), and time to progression (TTP) for this regimen at each of the two Dalteparin doses.

II. To evaluate the safety profile of this regimen in untreated MM patients, at each of the two Dalteparin doses.

III. To study the effect of Dalteparin alone, and in combination with lenalidomide/dexamethasone on serum biomarkers of multiple myeloma (MM) and thrombosis.

IV. To explore possible associations between the ORR and incidence of venous thromboembolism (VTE) with serial syndecan-1, IL-6, tyrosine aminotransferase (TAT), D-dimer, P-selectin levels.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive a prophylactic dose of dalteparin subcutaneously (SC) on days 1-28; lenalidomide orally (PO) on days 1-21; and low-dose dexamethasone PO on days 1, 8, 15, and 22.

ARM II: Patients receive a therapeutic dose of dalteparin SC on days 1-21 and lenalidomide PO and low-dose dexamethasone PO as in Arm I.

In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with residual responding disease may receive 2 additional courses. After completion of study treatment, patients are followed up every 3 months for up to 2 years.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a diagnosis of active MM requiring treatment, as diagnosed by a bone marrow biopsy within 8 weeks prior to study enrollment
  • Patients must not have received any previous treatment for MM (localized radiation therapy or single agent pulse steroid therapy for acute MM crises is permitted)
  • Life expectancy of greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky >= 50%)
  • Total bilirubin < 1.5 x upper limit of normal (ULN)
  • Transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) < 2.5 x ULN
  • Alkaline phosphatase < 2.5 ULN
  • Platelets >= 75,000 cells/mm3
  • Hemoglobin >= 8.0 g/dL
  • Absolute neutrophil count (ANC) > 1,000 cells/mm3 NOTE: Patients with platelet count < 75,000 or hemoglobin < 8.0 g/dl,or ANC <1,000 cell/mm3 secondary to extensive bone marrow disease can be enrolled at Principal Investigator's (PI) discretion with appropriate transfusion and/or cytokine support
  • Creatinine =< 2.5 mg/dL (=< 200 mmol/L) or creatinine clearance > 30 ml/min (as calculated by the Cockcroft-Gault formula)
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
  • All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
  • Willingness and ability to sign informed consent for the clinical trial

Exclusion Criteria:

  • Patients who have had any prior chemotherapy for MM; with the exception of pulse steroids for any myeloma-related acute events
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
  • Pregnant or lactating women
  • Active serious infections uncontrolled by antibiotics at the time of treatment initiation
  • Inability to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Failure to comply with birth control methods as described above
  • Any serious medical or psychiatric condition or reason that, in the PI's opinion, makes the patient unsuitable to participate in this clinical trial
  • Known to be human immunodeficiency virus (HIV) positive (if the status of HIV is not known and patient is not at risk, as determined by the PI, then the patient will not be specifically tested for HIV); HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with lenalidomide and/or dalteparin. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
  • 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 (organ-confined, early stage disease) after curative therapy
  • Patients with M protein >6 gm/dl prior to starting treatment will be excluded from the initial "run-in" cohort on both arms of the study, but will be eligible for the subsequent enrollment of patients who do not have a run-in phase with dalteparin
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Please refer to this study by its identifier: NCT01518465

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Celgene Corporation
Principal Investigator: Ann Mohrbacher, MD University of Southern California
  More Information

Responsible Party: University of Southern California Identifier: NCT01518465     History of Changes
Other Study ID Numbers: 16M-11-1
NCI-2011-03784 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: January 18, 2012
Last Updated: March 2, 2017

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Heparin, Low-Molecular-Weight
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 19, 2017